Devices and systems configured to fit around a tissue or organ and methods of using the same

ABSTRACT

Devices and systems to fit around a tissue or organ and methods of using the same. In at least one embodiment of an implantable device of the present disclosure, the implantable device comprises a first engaging component comprising a first rigid inner plate at least partially surrounded by a first flexible coating, a second engaging component comprising a second rigid inner plate at least partially surrounded by a coating selected from the group consisting of the first flexible coating and the second flexible coating, a first c-ring and a second c-ring coupled to the engaging components, and a cover flap coupled to either the first engaging component or the second engaging component and capable of either further coupling to the second engaging component when initially coupled to the first engaging component or further coupling to the first engaging component when initially coupled to the second engaging component.

PRIORITY

The present application is related to, claims the priority benefit of,and is a U.S. continuation application of, U.S. patent application Ser.No. 14/215,829, filed Mar. 17, 2014 and issued as U.S. Pat. No.9,980,841 on May 29, 2018, which a) is related to, and claims thepriority benefit of, U.S. Provisional Patent Application Ser. No.61/800,687 filed Mar. 15, 2013, and b) is related to, claims thepriority benefit of, and is a U.S. continuation-in-part patentapplication of, U.S. patent application Ser. No. 13/080,586, filed Apr.5, 2011, which is related to, claims the priority benefit of, and is aU.S. continuation-in-part patent application of, U.S. patent applicationSer. No. 12/861,251, filed Aug. 23, 2010, which is related to, claimsthe priority benefit of, and is a U.S. continuation-in-part patentapplication of, U.S. patent application Ser. No. 12/546,139, filed Aug.24, 2009. The contents of each of these applications and patents arehereby incorporated by reference in their entirety into this disclosure.

BACKGROUND

Organ and tissue surgical restoration are clinical techniques that maybe applied to numerous different body tissues, ranging from bloodvessels to whole organs. Conventionally, such surgical techniquesrequire the use of incisions, pins, staples and/or significant suturesin order to alter the tissue's anatomy. For example, surgical gastricrestoration often employed to treat obesity and typically involves thereorganization of the digestive tract. Conventional examples of suchprocedures involve attempts to either 1) restrict food intake into thebody via a restrictive bariatric procedure (a “Restrictive Procedure”),or 2) alter the anatomy of the small intestine or divert the peristalsisof a person's normal food intake past the small intestine to decreasecaloric absorption via a malabsorptive bariatric procedure, which iscommonly known as a gastric bypass (a “Malabsorptive Procedure”). It isalso known to combine the two procedures such that both of theaforementioned techniques are employed jointly.

Malabsorptive Procedures entail an intestinal bypass that results in theexclusion of almost all of the small intestine from the digestive tract.In most Malabsorbptive Procedures, a portion of the stomach or smallintestine is removed from the digestive tract through a surgicalprocedure that requires cutting the digestive tissue and thereafterclosing any holes or securing the newly formed anatomy with staplesand/or sutures. Conversely, Restrictive Procedures generally involve thecreation of a passageway extending from the upper portion of the stomachto the lower portion of the stomach in order to decrease the size of theorgan and thus prevent the stomach from storing large amounts of food.Conventional Restrictive Procedures rely on the banding, suturing and/orstapling of the stomach to create a small pouch on the superior portionof the stomach near the gastroesophageal junction.

Combined operations consisting of Malabsorptive and RestrictiveProcedures are the most common bariatric procedures performed today. Anexample of a combined procedure is the Extended (Distal) Roux-en-YGastric Bypass in which a stapling creates a small stomach pouch(approximately 15 to 20 cc) completely separated from the remainder ofthe stomach. In addition, the small intestine is divided just beyond theduodenum (the hollow tube connecting the stomach to the jejunum),re-arranged into a Y-configuration, and sutured to the small upperstomach pouch to enable the outflow of food therefrom through the newlyformed “Roux limb.”

Accordingly, most digestive tract restoration procedures require thatthe stomach and/or tissue of the intestine is cut and thereafter suturedor stapled back together. As the digestive tract contains numerousenzymes, strong acids and multiple species of bacteria that assist withdigestion, the perforation of an organ and/or tissue thereof isparticularly problematic due to the likelihood of leakage therefromand/or increased risk of serious infection. As such, conventionalgastric surgical restoration procedures have high rates ofpost-operative complications that may require prolonged hospitalizationand even additional operations, and are often irreversible and/orpermanently affect the restored tissue and/or organ. Accordingly, a needexists for safe and effective devices and methods for restoring organsand tissue that are reversible and do not require cutting or penetratingthe underlying tissue with significant sutures, staples and/or pins.

It will be appreciated that the foregoing examples are only provided asexamples and that there are numerous other indications whereintervention is necessary either to restore the underlying organ ortissue and/or to provide support thereto.

BRIEF SUMMARY

In at least one embodiment of an implantable restraining device of thepresent disclosure, the device comprises a first engaging component anda second engaging component, the first and second engaging componentsconfigured for laparoscopic insertion into a body cavity, and at leastone connector coupled to the first engaging component and the secondengaging component. In at least one embodiment, the at least oneconnector is capable of comprising a first configuration relative to thefirst engaging component and the second engaging component whereby thefirst engaging component and the second engaging component arepositioned relative to one another to fit within a laparoscopic port,and is further capable of comprising a second configuration relative tothe first engaging component and the second engaging component wherebythe first engaging component and the second engaging component arespaced apart from one another so that an interior space having a valueis defined therebetween. In an additional embodiment, the at least oneconnector is capable of moving between a first position that issubstantially parallel with the first engaging component and the secondengaging component, and a second position that is substantiallyperpendicular with the first engaging component and the second engagingcomponent. In yet another embodiment, the first engaging component andthe second engaging component are configured to engage a targeted tissuetherebetween when the at least one connector is/are in a secondconfiguration relative to the first engaging component and the secondengaging component.

In at least one embodiment of an implantable restraining device of thepresent disclosure, at least one of the first engaging component and thesecond engaging component further comprises one or more suturingelements chosen from the group of one or more pads, one or moreapertures, and/or one or more suture members, each of the one or moresuturing elements capable of receiving a suture therethrough. In anotherembodiment, the first engaging component and the second engagingcomponent further comprise one or more strings, wherein said strings maybe coupled to one another to secure the device about a stomach. In yetanother embodiment, the first engaging component and the second engagingcomponent each comprise a proximal end, a distal end, and a bodyextending therebetween, wherein the body of the first engaging componentis configured to conform to a first targeted tissue surface, and thebody of the second engaging component is configured to conform to asecond targeted tissue surface. In an additional embodiment, the atleast one connector is rotatably coupled with the body of the firstengaging component and the body of the second engaging component. In yetan additional embodiment, the at least one connector comprises a firstconnector and a second connector, wherein the first connector is coupledto the distal end of the first engaging component and the distal end ofthe second engaging component, and wherein the second connector iscoupled to the proximal end of the first engaging component and theproximal end of the second engaging component.

In at least one embodiment of an implantable restraining device of thepresent disclosure, each of the first engaging component and the secondengaging component comprise a configuration chosen from a straight barconfiguration, a curved configuration, or a circular configuration. Inan additional embodiment, the first engaging component and the secondengaging component are flexible or semi-flexible. In yet an additionalembodiment, the first engaging component, the second engaging component,and the at least one connector each comprise a material suitable toresist corrosion, the material chosen from polyurethane, polyethylene,polytetrafluoroethylene, nitinol, silastic, titanium, and/or stainlesssteel. In another embodiment, when a force is applied to the at leastone connector, the value of the interior space is increased.

In at least one embodiment of an implantable restraining device of thepresent disclosure, the at least one connector comprises at least onespring having at least one coil. In another embodiment, the at least onespring comprises at least one torsion spring. In yet another embodiment,the at least one coil of the at least one spring comprises three or morecoils. In an additional embodiment, an outermost diameter of the atleast one spring is less than about 15 millimeters. In a furtherembodiment, the at least one spring comprises a first rod and a secondrod extending from the coil, wherein the first rod is coupled to thefirst engaging component and the second rod is coupled to the secondengaging component.

In at least one embodiment of an implantable restraining device of thepresent disclosure, the value of the interior space defined between thefirst engaging component and the second engaging component when the atleast one connector comprises a second configuration corresponds to anouter dimension of a stomach so that the device, when positioned about astomach, fits about the stomach without providing any clamping pressureupon said stomach. In an additional embodiment, each of the firstengaging component and the second engaging component have a widthbetween 5 mm and 15 mm and have a length between 30 mm and 200 mm. Inyet an additional embodiment, when the at least one connector comprisesa first configuration, the at least one connector operates to compressthe first engaging component and the second engaging component towardone another so that the value of the interior space approaches zero. Inanother embodiment, the first engaging component further comprises oneor more pads affixed thereto, each of the one or more pads capable ofreceiving a suture therethrough.

In at least one embodiment of an implantable restraining device of thepresent disclosure, the at least one connector comprises at least onestrut, the at least one strut rotatably coupled to the first engagingcomponent and the second engaging component. In another embodiment, theat least one strut comprises at least two struts, and wherein the devicefurther comprises a mesh curtain coupled to at least two of the at leasttwo struts, the mesh curtain operable to limit organ distension orremodeling when the device is positioned about an organ. In anadditional embodiment, the mesh curtain defines at least one meshaperture, the at least one mesh aperture sized to permit a user to graspan organ within the at least one mesh aperture to facilitate positioningthe device about the organ. In yet an additional embodiment, said deviceis sized and shaped so that a demi shaft may engage the device so thatthe device may be positioned within a body cavity, and removal of thedemi shaft from the device allows the first engaging component and thesecond engaging component to separate from one another.

In at least one embodiment of an implantable restraining device of thepresent disclosure, the device further comprises a mesh curtain coupledto the first engaging component and the second engaging component, themesh curtain operable to limit organ distension or remodeling when thedevice is positioned about an organ. In another embodiment, the devicefurther comprises pliable junctions within the first engaging componentand the second engaging component to divide each component into twoseparate subcomponents, wherein each of the two separate subcomponentsof the first engaging component and the second engaging component areconnected to one another by way of a flexible structure.

In at least one embodiment of an implantable restraining device of thepresent disclosure, the at least one connector comprises at least twoconnectors, the at least two connectors each comprising a coupler, saidcoupler comprising at least two coupler arms connected to a coupler bar.In an additional embodiment, each of the first engaging component andthe second engaging component define apertures sized and shaped to fitsaid coupler arms so that said coupler arms may inserted within saidapertures. In yet an additional embodiment, at least one of the at leasttwo coupler arms comprises a coupler protrusion positioned at or near adistal end of said arms, and wherein the first engaging component andthe second engaging component comprise at least one stop at thecorresponding aperture where said arm comprises a coupler protrusion,the coupler protrusion sized and shaped to restrict removal of couplerfrom the first engaging component and the second engaging component uponengagement of said stop. In another embodiment, the at least two couplerarms of each coupler comprise a pivot member positioned therethrough sothat the at least two coupler arms may pivot about one another at thepivot member. In yet another embodiment, each of the first engagingcomponent and the second engaging component define apertures sized andshaped to fit said coupler arms so that said coupler arms may insertedwithin said apertures and so that said coupler arms may move in alateral direction corresponding to the first engaging component and thesecond engaging component. In an additional embodiment, one or moreprotrusions positioned within at least one aperture are capable offacilitating fixation of coupler arms in a desired position.

In at least one embodiment of an implantable restraining device of thepresent disclosure, the device comprises the first engaging componentand the second engaging component each define an opening, said openingsized and shaped to accept arms of an apparatus useful to position thedevice within a body cavity. In an additional embodiment, the at leastone connector comprises a resorbable material, and wherein when thedevice is positioned about a stomach, the at least one connector resorbswithin a body over time so that the at least one connector is no longercoupled to the first engaging component and the second engagingcomponent. In yet an additional embodiment, the first engaging componentand the second engaging component comprise a resorbable material, andwhen the device is positioned about a stomach, the first engagingcomponent and the second engaging component resorb within a body overtime so that the first engaging component and the second engagingcomponent are no longer coupled to one another by way of the at leastone connector. In another embodiment, at least one of the first engagingcomponent, the second engaging component, and the at least one connectorcomprise a resorbable material chosen from polyglycolide (PGA),polylactide (PLA), I-lactide (LPLA), poly(dl-lactide) (DLPLA),poly(.epsilon.-caprolactone) (PCL), poly(dioxanone) (PDO),polyglycolide-trimethylene carbonate (PGA-TMC), orpoly(d,l-lactide-co-glycolide) (DLPLG).

In at least one embodiment of an apparatus for delivering a restrainingdevice of the present disclosure, the apparatus comprises a shaftcomprising a distal end, the shaft defining a lumen positionedtherethrough, at least one arm operably coupled to the shaft at or nearthe distal end of the shaft, the at least one arm configured to engage arestraining device comprising a first engaging component, a secondengaging component, and at least one connector coupled to the firstengaging component and the second engaging component, and at least onepull bar having a distal end, the at least one pull par positioned atleast partially within the lumen of the shaft. In at least anotherembodiment, when a string coupled to the at least one connector isengaged by the at least one pull bar at or near the distal end of the atleast one pull bar, the at least one pull bar is operable to change theconfiguration of the at least one connector upon retraction of the atleast one pull bar within the lumen of the shaft. In an additionalembodiment, the at least one arm comprises a first arm and a second arm,the first arm operable to engage the first engaging component of therestraining device and the second arm operable to engage the secondengaging component of the restraining device. In yet an additionalembodiment, movement of the first arm and the second arm in a firstdirection facilitates the separation of the first engaging componentfrom the second engaging component.

In at least one embodiment of an apparatus for delivering a restrainingdevice of the present disclosure, the apparatus comprises a shaftcomprising a proximal end and a distal end, the shaft defining a lumenpositioned therethrough, at least one arm operably coupled to the shaftat or near the distal end of the shaft, the at least one arm configuredto engage a restraining device comprising a first engaging component, asecond engaging component, and at least one connector coupled to thefirst engaging component and the second engaging component, and at leastone string rotator, the at least one string rotator positioned at ornear the proximal end of the shaft, wherein when a string coupled to theat least one connector is engaged by the at least string rotator, the atleast one string rotator is operable to change the configuration of theat least one connector upon rotation of the at least one string rotator.

In at least one embodiment of a system for restoring a tissue of thepresent disclosure, the system comprises an exemplary implantablerestraining device of the present disclosure and an exemplary anapparatus for delivering the restraining device of the presentdisclosure.

In at least one embodiment of a method for restoring a targeted tissueof the present disclosure, the method comprising the steps of insertingan exemplary implantable restraining device of the present disclosureinto a body cavity, increasing the value of the interior space betweenthe first engaging component and the second engaging component of thedevice by positioning the at least one connector in a secondconfiguration, and positioning the first engaging component and thesecond engaging component of the device over the targeted tissue suchthat the targeted tissue is positioned within the interior space,wherein when the targeted tissue expands in a direction between thefirst engaging component and the second engaging component, the targetedtissue exerts a force upon the first engaging component and the secondengaging component. In another embodiment, the targeted tissue is astomach, and expansion of the stomach, with said device positionedthereon, functionally divides the stomach into a first stomach portionand a second stomach portion. In yet another embodiment, the targetedtissue is a stomach and wherein the first engaging component and thesecond engaging component comprise one or more suturing elementspositioned at or near the distal ends of each said component, the one ormore suturing elements capable of receiving a suture therethrough toapproximate the distal ends of said components toward one another. In anadditional embodiment, said approximation of the distal ends of thefirst engaging component and the second engaging component toward oneanother prevents a fistula so that food entering the stomach enters afirst stomach portion and not the stomach fundus. In yet an additionalembodiment, the distal ends of the first engaging component and thesecond engaging component extend beyond the stomach when the device ispositioned over the stomach.

In at least one embodiment of an implantable restraining device of thepresent disclosure, the device comprises a first engaging component anda second engaging component configured for laparoscopic insertion into abody cavity, wherein at least one of the first engaging component and/orthe second engaging component comprises one or more suturing elements,and wherein the first engaging component and the second engagingcomponent each comprise a material suitable to resist corrosion, and atleast one connector coupled to the first engaging component and thesecond engaging component, the at least one connector capable ofcomprising a first configuration relative to the first engagingcomponent and the second engaging component whereby the first engagingcomponent and the second engaging component are positioned relative toone another to fit within a laparoscopic port, the at least oneconnector capable of comprising a second configuration relative to thefirst engaging component and the second engaging component whereby thefirst engaging component and the second engaging component are spacedapart from one another so that an interior space having a value isdefined therebetween, wherein when the device is positioned about astomach, the device fits about the stomach without providing anyclamping pressure upon said stomach.

In at least one embodiment of a method for removing a restraining devicefrom a body of the present disclosure, the method comprising the stepsof withdrawing a restraining device from a tissue or organ to which itis positioned, configuring the restraining device fit within alaparoscopic port, and removing restraining device from the body throughthe laparoscopic port. In another embodiment, said method is preceded bythe step of positioning the laparoscopic port within the body tofacilitate removal of the restraining device. In yet another embodiment,the method further comprises the step of removing the laparoscopic portfrom the body.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device comprises a first engagingcomponent and a second engaging component, each component configured forlaparoscopic insertion into a body cavity, a first swivel arm defining afirst bend and a second swivel arm defining a second bend, the firstswivel arm coupled to the first engaging component at a first pivotpoint and coupled to the second engaging component at a second pivotpoint, and the second swivel arm coupled to the first engaging componentat a third pivot point and coupled to the second engaging component at afourth pivot point, and a first interconnection arm and a secondinterconnection arm, the first interconnection arm connected to thefirst swivel arm relative to the first bend, and the secondinterconnection arm connected to the second swivel arm relative to thesecond bend. In another embodiment, the first swivel arm and the secondswivel arm are capable of moving between a first position that issubstantially parallel with the first engaging component and the secondengaging component and a second position that is substantiallyperpendicular with the first engaging component and the second engagingcomponent. In yet another embodiment, the first engaging component andthe second engaging component are configured to engage a targeted tissuetherebetween when the first swivel arm and the second swivel arm are ina configuration relatively perpendicular to the first engaging componentand the second engaging component. In an additional embodiment, thefirst engaging component and the second engaging component each defineone or more studs sized and shaped to permit the first swivel arm andthe second swivel arm to be coupled thereto.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the first swivel arm and the secondswivel arm further define one or more curvatures, whereby the firstbend, the second bend, and the one or more curvatures define a nativeU-shaped configuration. In an additional embodiment, the device furthercomprises a tape positioned around at least part of the device so thatthe tape engages the first interconnection arm and the secondinterconnection arm. In another embodiment, the tape is capable ofdecreasing an interior space defined between the first engagingcomponent and the second engaging component when the tape applies aforce to the first interconnection arm and the second interconnectionarm. In yet another embodiment, the tape further comprises one or moredetectable portions positioned/imprinted thereon. In variousembodiments, the one or more detectable portions are radiopaque.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device further comprises a coverflap, the cover flap coupled to either the first engaging component orthe second engaging component, the cover flap capable of either furthercoupling to the second engaging component when initially coupled to thefirst engaging component or further coupling to the first engagingcomponent when initially coupled to the second engaging component. Inanother embodiment, the at least one of the first engaging component andthe second engaging component define one or more suture aperturestherethrough. In yet another embodiment, the first engaging componentand the second engaging component each comprise a proximal end, a distalend, and a body extending therebetween, wherein the body of the firstengaging component is configured to conform to a first targeted tissuesurface, and the body of the second engaging component is configured toconform to a second targeted tissue surface.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device further comprises a firstadjustment rod and a second adjustment rod, each of the first adjustmentrod and the second adjustment rod comprising a distal end, a proximalend, and threading therebetween, and a dial rotatably coupled thereto ator near the threading. In another embodiment, the first adjustment rodis coupled to the first swivel arm and the first interconnection arm,and wherein the second adjustment rod is coupled to the second swivelarm and the second interconnection arm. In yet another embodiment,rotation of the dial on either or both of the first adjustment rodand/or the second adjustment rod facilitates movement of the firstengaging component and the second engaging component. In an additionalembodiment, rotation of the dial in a first direction causes the firstengaging component and the second engaging component to move toward oneanother, and wherein rotation of the dial in a second direction causesthe first engaging component and the second engaging component to moveaway from one another.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, each of the first adjustment rod andthe second adjustment rod further comprises a bar coupled thereto at ornear the distal ends of said rods. In an additional embodiment the barcoupled to the first adjustment rod is positioned distal to the firstinterconnection arm, and wherein the bar coupled to the secondadjustment rod is positioned distal to the second interconnection arm,and wherein rotation of the dial on either or both of the firstadjustment rod and/or the second adjustment rod facilitates movement ofthe first engaging component and the second engaging component. In yetan additional embodiment each of the first adjustment rod and the secondadjustment rod further comprises a cap coupled thereto at or near theproximal ends of said rods, said caps configured to prevent said dialsfrom disengaging said adjustment rods. In another embodiment, said dialsdefine a dial aperture therethrough, the dial configured to permit anindicia present upon said adjustment rods to be viewed therethrough. Inyet another embodiment, each of the first engaging component and thesecond engaging component define one or more facets along at least partof a length of said engaging components, said facets providing agenerally arcuate profile of said engaging components.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, each of the first engaging componentand the second engaging component comprise a configuration chosen from astraight bar configuration, a curved configuration, or a circularconfiguration. In an additional embodiment, the first engaging componentand the second engaging component are flexible or semi-flexible. Invarious embodiments, the first engaging component, the second engagingcomponent, the first swivel arm, and the second swivel arm each comprisea material suitable to resist corrosion selected from the groupconsisting of polyurethane, polyethylene, polytetrafluoroethylene,nitinol, silastic, titanium, and stainless steel. In variousembodiments, the first engaging component, the second engagingcomponent, the first swivel arm, and the second swivel arm comprise aresorbable material selected from the group consisting of polyglycolide(PGA), polylactide (PLA), l-lactide (LPLA), poly(dl-lactide) (DLPLA),poly(c-caprolactone) (PCL), poly(dioxanone) (PDO),polylglycolide-trimethylene carbonate (PGA-TMC), orpoly(d,l-lactide-co-glycolide) (DLPLG).

In at least one exemplary embodiment of implantable restraining deviceof the present disclosure, the device comprises a first engagingcomponent defining a first bend and a second engaging component defininga second bend, the first and second engaging components configured forlaparoscopic insertion into a body cavity, a first swivel arm and asecond swivel arm, the first swivel arm coupled to the first engagingcomponent at a first pivot point and coupled to the second engagingcomponent at a second pivot point, and the second swivel arm coupled tothe first engaging component at a third pivot point and coupled to thesecond engaging component at a fourth pivot point, a firstinterconnection arm and a second interconnection arm, the firstinterconnection arm connected to the first swivel arm relative to thefirst bend, and the second interconnection arm connected to the secondswivel arm relative to the second bend, a tape positioned around atleast part of the device so that the tape engages the firstinterconnection arm and the second interconnection arm, and a coverflap, the cover flap coupled to either the first engaging component orthe second engaging component, the cover flap capable of either furthercoupling to the second engaging component when initially coupled to thefirst engaging component or further coupling to the first engagingcomponent when initially coupled to the second engaging component,wherein the first swivel arm and the second swivel arm are capable ofmoving between a first position that is substantially parallel with thefirst engaging component and the second engaging component and a secondposition that is substantially perpendicular with the first engagingcomponent and the second engaging component.

In at least one exemplary embodiment of implantable restraining deviceof the present disclosure, the device comprises a first engagingcomponent and a second engaging component, each component configured forlaparoscopic insertion into a body cavity, a first swivel arm defining afirst bend and a second swivel arm defining a second bend, the firstswivel arm coupled to the first engaging component at a first pivotpoint and coupled to the second engaging component at a second pivotpoint, and the second swivel arm coupled to the first engaging componentat a third pivot point and coupled to the second engaging component at afourth pivot point, a first interconnection arm and a secondinterconnection arm, the first interconnection arm connected to thefirst swivel arm relative to the first bend, and the secondinterconnection arm connected to the second swivel arm relative to thesecond bend, a first adjustment rod and a second adjustment rod, each ofthe first adjustment rod and the second adjustment rod comprising adistal end, a proximal end, and threading therebetween, a dial rotatablycoupled thereto at or near the threading, and a bar coupled thereto ator near the distal ends of said adjustment rods, wherein the firstadjustment rod is coupled to the first swivel arm and the firstinterconnection arm, and wherein the second adjustment rod is coupled tothe second swivel arm and the second interconnection arm, whereinrotation of the dial in a first direction causes the first engagingcomponent and the second engaging component to move toward one another,and wherein rotation of the dial in a second direction causes the firstengaging component and the second engaging component to move away fromone another, and wherein the first swivel arm and the second swivel armare capable of moving between a first position that is substantiallyparallel with the first engaging component and the second engagingcomponent and a second position that is substantially perpendicular withthe first engaging component and the second engaging component.

In at least one exemplary embodiment of a method for restoring atargeted tissue of the present disclosure, the method comprises thesteps of inserting an implantable restraining device into a body cavityof a mammalian body, the implantable restraining device comprising afirst engaging component defining a first bend and a second engagingcomponent defining a second bend, the first and second engagingcomponents configured for laparoscopic insertion into a body cavity, afirst swivel arm and a second swivel arm, the first swivel arm coupledto the first engaging component at a first pivot point and coupled tothe second engaging component at a second pivot point, and the secondswivel arm coupled to the first engaging component at a third pivotpoint and coupled to the second engaging component at a fourth pivotpoint, and a first interconnection arm and a second interconnection arm,the first interconnection arm connected to the first swivel arm relativeto the first bend, and the second interconnection arm connected to thesecond swivel arm relative to the second bend, advancing the implantablerestraining device to a location within the mammalian body adjacent to atargeted tissue, swiveling the first swivel arm and the second swivelarm so that the first swivel arm and the second swivel arm aresubstantially perpendicular to the first engaging component and thesecond engaging component, and positioning the first engaging componentand the second engaging component over the targeted tissue such that atleast a portion of the targeted tissue is positioned therebetween,wherein when the targeted tissue expands in a direction between thefirst engaging component and the second engaging component, the targetedtissue exerts a force upon the first engaging component and the secondengaging component. In another embodiment, the method further comprisesthe step of securing one or more sutures to connect the first engagingcomponent and/or the second engaging component to the targeted tissue.In yet another embodiment, the method further comprises the step ofsecuring a cover flap coupled to either the first engaging component orthe second engaging component so that the cover flap capable is eitherfurther coupled to the second engaging component when initially coupledto the first engaging component or further coupled to the first engagingcomponent when initially coupled to the second engaging component. In anadditional embodiment, the method further comprises the step ofadjusting a tape positioned around at least part of the device wherebythe tape engages the first interconnection arm and the secondinterconnection arm, wherein adjustment of the tape decreases aninterior space defined between the first engaging component and thesecond engaging component when the tape applies a force to the firstinterconnection arm and the second interconnection arm, and whereinadjustment of the tape increases an interior space defined between thefirst engaging component and the second engaging component when theforce is removed or reduced. In various embodiments, the targeted tissueis a stomach, and wherein expansion of the stomach, with said devicepositioned thereon, functionally divides the stomach into a firststomach portion and a second stomach portion. In at least anotherembodiment, the implantable restraining device further comprises a firstadjustment rod and a second adjustment rod, each of the first adjustmentrod and the second adjustment rod having a dial rotatably coupledthereto, wherein the first adjustment rod is coupled to the first swivelarm and the first interconnection arm, and wherein the second adjustmentrod is coupled to the second swivel arm and the second interconnectionarm, and wherein the method further comprises the step, of rotating saiddials to adjust an interior space between the first engaging componentand the second engaging component.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device comprises a first engagingcomponent and a second engaging component at least substantiallyparallel to one another, a first swivel arm, comprising a first fixedarm, a first expandable arm, and a first hub, wherein the first fixedarm is pivotally connected to the first engaging component at or near afirst fixed arm first end and is coupled to the first hub at or near afirst fixed arm second end, and wherein the first expandable arm ispivotally connected to the second engaging component at or near a firstexpandable arm first end and is connected to the first hub at or near afirst expandable arm second end by way of a first hub bracket, a secondswivel arm, comprising a second fixed arm, a second expandable arm, anda second hub, wherein the second fixed arm is pivotally connected to thefirst engaging component at or near a second fixed arm first end and iscoupled to the second hub at or near a second fixed arm second end, andwherein the second expandable arm is pivotally connected to the secondengaging component at or near a second expandable arm first end and isconnected to the second hub at or near a second expandable arm secondend by way of a second hub bracket, and wherein the first expandable armand the second expandable are capable of movement relative to the firsthub and the second hub respectively so that a distance between the firstengaging component and the second engaging component may change relativeto movement of the first expandable arm and the second expandable arm.In another embodiment, the first swivel arm is capable of rotation in afirst direction, and wherein the second swivel arm is capable ofrotation in an opposing second direction. In yet another embodiment, thefirst swivel arm and the second swivel arm are capable of rotation sothat the first swivel arm, the second swivel arm, the first engagingcomponent, and the second engaging component share a common linear axis.In an additional embodiment, the first swivel arm and the second swivelarm are capable of rotation so that the first swivel arm and the secondswivel arm are substantially or fully perpendicular to the firstengaging component and the second engaging component. In yet anadditional embodiment, the first fixed arm is relatively shorter thanthe second fixed arm, and wherein the first expandable arm is relativelyshorter than the second expandable arm.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device further comprises a firstarm flange at or near the first expandable arm second end, the first armflange configured to limit expansion of the first expandable armrelative to the first fixed arm, and a second arm flange at or near thesecond expandable arm second end, the second arm flange configured tolimit expansion of the second expandable arm relative to the secondfixed arm. In an additional embodiment, the device is sized and shapedto fit within a laparoscopic bodily port.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device further comprises a firststrap positioned at a first end of the first engaging component and at afirst end of the second engaging component, the first strap configuredto limit movement of the first engaging component and the secondengaging component when the first strap is coupled to the first engagingcomponent and the second engaging component. In an additionalembodiment, the first strap is fixedly coupled to one of the first endof the first engaging component or the first end of the second engagingcomponent. In yet an additional embodiment, the first strap is coupledto one of the first end of the first engaging component or the first endof the second engaging component by way of at least one suture. Inanother embodiment, the first strap has at least one suture aperturedefined therethrough, and wherein at least one of the first engagingcomponent and the second engaging component has at least one plateaperture defined therethrough, the at least one suture aperture and theat least one plate aperture configured to permit a suture to be placedtherethrough to couple the first strap to either the first engagingcomponent or the second engaging component.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device further comprises a firstpad coupled to one or both of the first fixed arm and the firstexpandable arm, and a second pad coupled to one or both of the secondfixed arm and the second expandable arm, wherein the first pad and thesecond pad are configured to engage at least a portion of a mammalianbodily organ positioned therebetween. In another embodiment, the firstengaging component and the second engaging component are configured toengage a targeted tissue therebetween when the first swivel arm and thesecond swivel arm are in a configuration relatively perpendicular to thefirst engaging component and the second engaging component. In yetanother embodiment, the first engaging component, the second engagingcomponent, the first swivel arm, and the second swivel arm each comprisea material suitable to resist corrosion selected from the groupconsisting of polyurethane, polyethylene, polytetrafluoroethylene,polyaryletherketone, carbothane, tecothane, nitinol, silastic, titanium,and stainless steel.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, each of the first engaging componentand the second engaging component define one or more facets along atleast part of a length of said engaging components, said facetsproviding a generally arcuate profile of said engaging components. In anadditional embodiment, each of the first engaging component and thesecond engaging component comprise a configuration chosen from astraight bar configuration, a curved configuration, or a circularconfiguration. In yet an additional embodiment, the first engagingcomponent and the second engaging component are flexible orsemi-flexible.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device comprises a first engagingcomponent and a second engaging component at least substantiallyparallel to one another, a first swivel arm, comprising a first fixedarm, a first expandable arm, and a first hub, wherein the first fixedarm is pivotally connected to the first engaging component at or near afirst fixed arm first end and is coupled to the first hub at or near afirst fixed arm second end, and wherein the first expandable arm ispivotally connected to the second engaging component at or near a firstexpandable arm first end and is connected to the first hub at or near afirst expandable arm second end by way of a first hub bracket, a secondswivel arm, comprising a second fixed arm, a second expandable arm, anda second hub, wherein the second fixed arm is pivotally connected to thefirst engaging component at or near a second fixed arm first end and iscoupled to the second hub at or near a second fixed arm second end, andwherein the second expandable arm is pivotally connected to the secondengaging component at or near a second expandable arm first end and isconnected to the second hub at or near a second expandable arm secondend by way of a second hub bracket, and a first strap positioned at oneor both of a first end of the first engaging component and at a firstend of the second engaging component, the first strap configured tolimit movement of the first engaging component and the second engagingcomponent when the first strap is coupled to the first engagingcomponent and the second engaging component. wherein the firstexpandable arm and the second expandable are capable of movementrelative to the first hub and the second hub respectively so that adistance between the first engaging component and the second engagingcomponent may change relative to movement of the first expandable armand the second expandable arm, and wherein the first swivel arm iscapable of rotation in a first direction so that the first swivel arm,the second swivel arm, the first engaging component, and the secondengaging component share a common linear axis, and wherein the secondswivel arm is capable of rotation in an opposing second direction sothat the first swivel arm and the second swivel arm are substantially orfully perpendicular to the first engaging component and the secondengaging component.

In at least one embodiment of a method for restoring a targeted tissueof the present disclosure, the method comprises the steps of insertingan implantable restraining device into a body cavity of a mammalianbody, the implantable restraining device comprising a first engagingcomponent and a second engaging component at least substantiallyparallel to one another, a first swivel arm, comprising a first fixedarm, a first expandable arm, and a first hub, wherein the first fixedarm is pivotally connected to the first engaging component at or near afirst fixed arm first end and is coupled to the first hub at or near afirst fixed arm second end, and wherein the first expandable arm ispivotally connected to the second engaging component at or near a firstexpandable arm first end and is connected to the first hub at or near afirst expandable arm second end by way of a first hub bracket, a secondswivel arm, comprising a second fixed arm, a second expandable arm, anda second hub, wherein the second fixed arm is pivotally connected to thefirst engaging component at or near a second fixed arm first end and iscoupled to the second hub at or near a second fixed arm second end, andwherein the second expandable arm is pivotally connected to the secondengaging component at or near a second expandable arm first end and isconnected to the second hub at or near a second expandable arm secondend by way of a second hub bracket, advancing the implantablerestraining device to a location within the mammalian body adjacent to atargeted tissue, swiveling the first swivel arm and the second swivelarm so that the first swivel arm and the second swivel arm aresubstantially perpendicular to the first engaging component and thesecond engaging component, and positioning the first engaging componentand the second engaging component over the targeted tissue such that atleast a portion of the targeted tissue is positioned therebetween,wherein when the targeted tissue expands in a direction between thefirst engaging component and the second engaging component, the targetedtissue exerts a force upon the first engaging component and the secondengaging component so that the first expandable arm moves relative tothe first hub and so that the second expandable arm moves relative tothe second hub. In another embodiment, the targeted tissue is a stomach,and wherein expansion of the stomach, with said device positionedthereon, functionally divides the stomach into a first stomach portionand a second stomach portion.

In at least one embodiment of an implantable device of the presentdisclosure, the implantable device comprises a first engaging componentcomprising a first rigid inner plate at least partially surrounded by afirst flexible coating, a second engaging component comprising a secondrigid inner plate at least partially surrounded by a coating selectedfrom the group consisting of the first flexible coating and the secondflexible coating, a first c-ring and a second c-ring, the first c-ringcoupled to the first engaging component at a first pivot point andcoupled to the second engaging component at a second pivot point, andthe second c-ring coupled to the first engaging component at a thirdpivot point and coupled to the second engaging component at a fourthpivot point, and a cover flap, the cover flap coupled to either thefirst engaging component or the second engaging component, the coverflap capable of either further coupling to the second engaging componentwhen initially coupled to the first engaging component or furthercoupling to the first engaging component when initially coupled to thesecond engaging component, wherein each of the first engaging componentand the second engaging component define a longitudinal axis, whereinthe device is further configured for placement around at least part of astomach, and wherein the first c-ring and the second c-ring areconfigured to move from a first position that is substantially coplanarwith the first engaging component and the second engaging component to asecond position that is substantially perpendicular with the firstengaging component and the second engaging component so to open thedevice, said movement in a plane perpendicular to a plane defined by aninterior space between the first engaging component and the secondengaging component. In an additional embodiment, when the first c-ringand the second c-ring are not positioned within the interior spacebetween the first engaging component and the second engaging componentwhen in the second position when the device is open. In yet anadditional embodiment, the first flexible coating extends beyond aperimeter of the first rigid plate and wherein the second flexiblecoating extends beyond a perimeter of the second rigid plate. In anadditional embodiment, when the first flexible coating extends beyond aperimeter of the first rigid plate and when the second flexible coatingextends beyond a perimeter of the second rigid plate, the first flexiblecoating and the second flexible coating prevents shearing and migrationof the device when the first engaging component and the second engagingcomponent contact the stomach.

In at least one embodiment of an implantable device of the presentdisclosure, the device further comprises a first swivel stop positionedalong at least one of the first engaging component and the secondengaging component, the first swivel stop configured to limit swivelingof the first c-ring, and a second swivel stop positioned along at leastone of the first engaging component and the second engaging component,the second swivel stop configured to limit swiveling of the secondc-ring. In an additional embodiment, at least one of the first c-ringand the second c-ring comprises at least one suture feature. In yet anadditional embodiment, the cover flap comprises a first materialsurrounded at least substantially by a coating selected from the groupconsisting of the first flexible coating, the second flexible coating,and a third coating. In an additional embodiment, at least one tabaperture is defined within the cover flap, wherein one of the firstengaging component and the second engaging component further comprises atab, and wherein the tab is configured for insertion into the tabaperture. In yet an additional embodiment, one of the first engagingcomponent and the second engaging component further comprises a loopcoupled thereto, wherein at least a portion of the cover flap isconfigured to fit within the loop.

In at least one embodiment of an implantable device of the presentdisclosure, one of the first engaging component and the second engagingcomponent comprises a component tab configured to fit within a tabreceiver of at the other of the first engaging component and the secondengaging component. In an additional embodiment, at least one of thefirst c-ring and the second c-ring comprises a first c-ring portion anda second c-ring portion. In yet an additional embodiment, the firstc-ring portion and the second c-ring portion are coupled to one anotherby a coupler positioned at a pivot point. In an additional embodiment,the first c-ring portion and the second c-ring portion are configured topivot about one another at the pivot point. In yet an additionalembodiment, one of the first c-ring portion and the second c-ringportion comprises a post, wherein the other of the first c-ring portionand the second c-ring portion has a post aperture defined therein, andwherein the post aperture is configured to receive the post.

In at least one embodiment of an implantable device of the presentdisclosure, the first c-ring portion and the second c-ring portion areconfigured to move relative to one another when the post moves relativeto the post aperture. In an additional embodiment, the first c-ringportion and the second c-ring portion are coupled to one another by aslider coupler coupled to one of the first c-ring portion and the secondc-ring portion. In yet an additional embodiment, an engagement mechanismof one of the first c-ring portion and the second c-ring portion isconfigured to engage the slider coupler. In an additional embodiment,one of the first c-ring portion and the second c-ring portion comprisesa joiner defining an inner threaded portion, wherein the other of thefirst c-ring portion and the second c-ring portion has an outer threadedportion, and wherein the inner threaded portion is configured to receivethe outer threaded portion. In yet an additional embodiment, one of thefirst c-ring portion and the second c-ring portion comprises a c-ringstub, wherein the other of the first c-ring portion and the secondc-ring portion has a post c-ring stub aperture defined therein, andwherein the c-ring stub aperture is configured to receive the c-ringstub.

In at least one embodiment of an implantable device of the presentdisclosure, the first c-ring portion and the second c-ring portion areconfigured to move relative to one another when the c-ring stub movesrelative to the c-ring stub aperture. In an additional embodiment, thedevice further comprises a cover positioned around a portion of thefirst c-ring and the second c-ring at or near the c-ring stub. In yet anadditional embodiment, the first c-ring portion and the second c-ringportion are coupled to one another by hinge coupled to the first c-ringportion and the second c-ring portion. In an additional embodiment, thefirst c-ring portion and the second c-ring portion can move relative toone another and relative to the hinge by way of at least two pivotpoints. In yet an additional embodiment, at least one of the firstc-ring and the second c-ring comprises or is coupled to an elongatedcoupler having at least one living hinge defined therein.

In at least one embodiment of an implantable device of the presentdisclosure, the elongated coupler is configured to bend at he at leastone living hinge. In an additional embodiment, the elongated coupler isconfigured to connect to a portion of a second elongated coupler coupledto the first c-ring or the second c-ring that is not coupled to theelongated coupler. In yet an additional embodiment, at least one of thefirst c-ring and the second c-ring comprises a metal insert at leastsubstantially surrounded by a coating selected from the group consistingof the first flexible coating, the second flexible coating, and a thirdcoating. In an additional embodiment, the first engaging component andthe second engaging component are configured to engage a targeted tissuetherebetween when the first c-ring and the second c-ring are in aconfiguration relatively perpendicular to the first engaging componentand the second engaging component. In yet an additional embodiment, atleast one of the first engaging component and the second engagingcomponent define one or more suture apertures therethrough.

In at least one embodiment of an implantable device of the presentdisclosure, the first engaging component and the second engagingcomponent each comprise a proximal end, a distal end, and a bodyextending therebetween, wherein the body of the first engaging componentis configured to conform to a first targeted tissue surface, and thebody of the second engaging component is configured to conform to asecond targeted tissue surface. In an additional embodiment, each of thefirst engaging component and the second engaging component define one ormore facets along at least part of a length of said engaging components,said facets providing a generally arcuate profile of said engagingcomponents. In yet an additional embodiment, each of the first engagingcomponent and the second engaging component comprise a configurationchosen from a straight bar configuration, a curved configuration, or acircular configuration. In an additional embodiment, the first engagingcomponent and the second engaging component are flexible orsemi-flexible. In yet an additional embodiment, the first engagingcomponent, the second engaging component, the first c-ring, and thesecond c-ring each comprise a material suitable to resist corrosionselected from the group consisting of polyurethane, polyethylene,polytetrafluoroethylene, nitinol, silastic, titanium, and stainlesssteel.

In at least one embodiment of an implantable device of the presentdisclosure, the first engaging component, the second engaging component,the first c-ring, and the second c-ring comprise a resorbable materialselected from the group consisting of polyglycolide (PGA), polylactide(PLA), l-lactide (LPLA), poly(dl-lactide) (DLPLA),poly(.epsilon.-caprolactone) (PCL), poly(dioxanone) (PDO),polylglycolide-trimethylene carbonate (PGA-TMC), orpoly(d,l-lactide-co-glycolide) (DLPLG). In an additional embodiment, thedevice is configured for laparascopic insertion into a body cavity.

In at least one embodiment of method for using an implantable device ofthe present disclosure, the method comprising the steps of inserting animplantable device into a mammalian body, the implantable devicecomprising a first engaging component comprising a first rigid innerplate at least partially surrounded by a first flexible coating, asecond engaging component comprising a second rigid inner plate at leastpartially surrounded by a coating selected from the group consisting ofthe first flexible coating and the second flexible coating, a firstc-ring and a second c-ring, the first c-ring coupled to the firstengaging component at a first pivot point and coupled to the secondengaging component at a second pivot point, and the second c-ringcoupled to the first engaging component at a third pivot point andcoupled to the second engaging component at a fourth pivot point, and acover flap, the cover flap coupled to either the first engagingcomponent or the second engaging component, the cover flap capable ofeither further coupling to the second engaging component when initiallycoupled to the first engaging component or further coupling to the firstengaging component when initially coupled to the second engagingcomponent, wherein each of the first engaging component and the secondengaging component define a longitudinal axis, advancing the implantabledevice to a location within the mammalian body adjacent to a targetedtissue, swiveling the first c-ring and the second c-ring so that thefirst c-ring and the second c-ring are substantially perpendicular tothe first engaging component and the second engaging component, andpositioning the first engaging component and the second engagingcomponent over the targeted tissue such that at least a portion of thetargeted tissue is positioned therebetween. In another embodiment, whenthe targeted tissue expands in a direction between the first engagingcomponent and the second engaging component, the targeted tissue exertsa force upon the first engaging component and the second engagingcomponent. In yet another embodiment, the step of inserting is performedlaparoscopically. In an additional embodiment, the step of inserting isperformed surgically.

In at least one embodiment of method for using an implantable device ofthe present disclosure, the step of positioning is performed to positionthe first engaging component and the second engaging component over atleast part of a stomach. In an additional embodiment, the method isperformed to treat an obese patient. In yet an additional embodiment,the method is performed so that a patient using the implantable devicecan achieve satiety faster than if the implantable device was not used.In another embodiment, the method is performed to reduce a potentialamount of food intake by reducing or eliminating an amount of food thatcan enter a fundus of the stomach. In yet another embodiment, the stepof swiveling is performed to move the first c-ring and the second c-ringfrom a first position that is substantially coplanar with the firstengaging component and the second engaging component to a secondposition that is substantially perpendicular with the first engagingcomponent and the second engaging component so to open the implantabledevice, said movement in a plane perpendicular to a plane defined by aninterior space between the first engaging component and the secondengaging component.

In at least one embodiment of method for using an implantable device ofthe present disclosure, the method further comprises the step ofsecuring one or more sutures to connect the first engaging componentand/or the second engaging component to the targeted tissue. In anotherembodiment, the method further comprises the step of securing the coverflap so that the cover flap is secured to the first engaging componentand the second engaging component. In yet another embodiment, whereinthe targeted tissue is a stomach, and wherein expansion of the stomach,with said device positioned thereon, functionally divides the stomachinto a first stomach portion and a second stomach portion. In anadditional embodiment, the method further comprises the step of securingthe cover flap over a fundus of the stomach so that the cover flap issecured to the first engaging component and the second engagingcomponent.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 show perspective views of at least one embodiment of arestraining device for restoring and/or supporting a tissue or organ ofthe present disclosure;

FIG. 3A shows a top view of at least one embodiment of a restrainingdevice for restoring and/or supporting a tissue or organ according tothe present disclosure;

FIGS. 3B through 3E show various embodiments of engaging componentsaccording to the present disclosure;

FIG. 4A shows a side view of the restraining device of FIGS. 1A and 1Bapplied in a longitudinal fashion to a stomach according to the presentdisclosure;

FIG. 4B shows a cross-sectional view of a restored stomach along lineA-A of FIG. 4;

FIGS. 5A through 5D show various embodiments of restraining devicespositioned about a stomach according to the present disclosure;

FIG. 6 shows a flow chart of a method for laparoscopically deliveringembodiments of the restraining device disclosed herein to a targetedtissue according to the present disclosure;

FIGS. 7A, 7B, and 8 show various embodiments of a restraining devicecomprising one or more struts according to the present disclosure;

FIG. 9 shows an exemplary embodiment of a restraining device comprisingtwo springs and a mesh curtain according to the present disclosure;

FIG. 10 shows an exemplary embodiment of a restraining device comprisinga pliable junction according to the present disclosure;

FIG. 11 shows a restraining device positioned within a laparoscopic portaccording to the present disclosure;

FIGS. 12A, 12B, 13A, and 13B show various embodiments of a restrainingdevice comprising a coupler according to the present disclosure;

FIGS. 14A and 14B show exemplary embodiments of a restraining devicecomprising a coupler and a coupler pivot according to the presentdisclosure;

FIGS. 15A and 15B show exemplary embodiments of an apparatus fordelivering a restraining device according to the present disclosure;

FIGS. 16A and 16B show exemplary embodiments of an apparatus fordelivering a restraining device comprising a coupler according to thepresent disclosure;

FIGS. 17A and 17B show additional exemplary embodiments of an apparatusfor delivering a restraining device according to the present disclosure;

FIG. 18 shows an exemplary embodiment of an apparatus perpendicularlyengaging a restraining device according to the present disclosure;

FIG. 19 shows a flow chart of a method for laparoscopically removingembodiments of the restraining device disclosed herein from a targetedtissue according to the present disclosure;

FIG. 20 shows a perspective view of at least another embodiment of arestraining device for restoring and/or supporting a tissue or organ ofthe present disclosure;

FIG. 21 shows an exemplary embodiment of a restraining device positionedabout a stomach according to the present disclosure;

FIG. 22 shows steps of an exemplary method of inserting, delivering, andplacing a restraining device about a targeted tissue according to thepresent disclosure;

FIG. 23 shows a perspective view of at least another embodiment of arestraining device for restoring and/or supporting a tissue or organ ofthe present disclosure;

FIG. 24 shows a side view of the embodiment of a restraining deviceshown in FIG. 23;

FIG. 25 shows a perspective view of an embodiment of an adjustment rodof the present disclosure;

FIG. 26 shows a side view of the embodiment of an adjustment rod shownin FIG. 25;

FIG. 27 shows a side view of an embodiment of an adjustment rod coupledto at least another component of an exemplary restraining device of thepresent disclosure;

FIG. 28 shows another perspective view of the embodiment of arestraining device shown in FIG. 23;

FIG. 29 shows steps of another exemplary method of inserting,delivering, and placing a restraining device about a targeted tissueaccording to the present disclosure;

FIG. 30 shows a perspective view of an exemplary embodiment of arestraining device of the present disclosure in a relatively openconfiguration;

FIG. 31 shows a perspective view of an exemplary embodiment of arestraining device of the present disclosure in a relatively openconfiguration;

FIGS. 32 and 33 show top views of an exemplary embodiment of arestraining device of the present disclosure;

FIG. 34 shows a side view of an exemplary embodiment of a restrainingdevice of the present disclosure in a relatively closed configuration;

FIG. 35 shows a perspective view of an exemplary embodiment of arestraining device of the present disclosure in a relatively closedconfiguration;

FIG. 36 shows a side view of an exemplary swivel arm of the presentdisclosure;

FIG. 37 shows a perspective view of an exemplary swivel arm of thepresent disclosure;

FIG. 38 shows a side view of another exemplary swivel arm of the presentdisclosure;

FIG. 39 shows a perspective view of another exemplary swivel arm of thepresent disclosure;

FIGS. 40, 41, and 42 show exemplary embodiments of restraining devicesof the present disclosure positioned about a stomach; and

FIGS. 43 and 44 show perspective views of devices, according toexemplary embodiments of the present disclosure;

FIGS. 45A, 45B, and 45C show portions of straps, according to exemplaryembodiments of the present disclosure;

FIG. 46 shows portions of engaging components and a strap, according toan exemplary embodiment of the present disclosure;

FIGS. 47A-52B show first and second c-ring portions coupled to orconfigured for coupling to each other, according to exemplaryembodiments of the present disclosure;

FIGS. 53A and 53B show a first elongated coupler and a first elongatedcoupler coupled to a second elongated coupler, respectively, accordingto exemplary embodiments of the present disclosure;

FIG. 54 shows a perspective view of a device, according to an exemplaryembodiment of the present disclosure; and

FIGS. 55A and 55B show cross-sectional views of exemplary engagingcomponents, according to exemplary embodiments of the presentdisclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of this disclosure is thereby intended.

FIGS. 1 and 2 show perspective views of at least one embodiment of arestraining device 10 for restoring a tissue or organ. In at least oneembodiment of the restraining device 10, the restraining device 10comprises an implantable device and does not require substantialsutures, staples or pins to be secured on the targeted tissue or organof interest. Further, the restraining device 10 described herein isconfigured to loosely, albeit securely, engage to the targeted tissuesuch that the underlying tissue is either uncompressed or only looselycompressed. The various embodiments of the restraining device 10described herein may be available for temporary or chronic placementwithin a patient's body, and the restoration procedures performedthrough the use of an exemplary device 10 are reversible throughminimally invasive procedures.

As shown in FIGS. 1 and 2, at least one embodiment of the restrainingdevice 10 comprises a first engaging component 12 and a second engagingcomponent 16. The first engaging component 12 may comprise a first shapeand the second engaging component 16 may comprise a second shape thatcorresponds to at least a portion of the first shape of the firstengaging component 12. For example, and without limitation, the firstand second engaging components 12, 16 may be configured in a barconfiguration as shown in FIGS. 1 and 2. Alternatively, the first andsecond engaging components 12, 16 may be configured in a contoured,circular or any other configuration suitable for use as referencedherein. Additionally, the first and second engaging components 12, 16may be configured such that the shape of each of the components 12, 16defines an interior area (not shown). It will be understood that thefirst and second engaging components 12, 16 of an exemplary restrainingdevice 10 may be configured in any shape and may also be flexible,semi-flexible, or articulated. Furthermore, it is contemplated that aclinician may select the desired configuration of the components 12, 16of the restraining device 10 based on the particular patient to betreated and/or pursuant to the specific application for which therestraining device 10 will be used to ensure that the restraining device10 appropriately conforms to the tissue or organ of interest. Forexample, an exemplary embodiment of a restraining device 10 of thepresent disclosure may comprise first and second engaging components 12,16 having a width of approximately 14 mm and a length of approximately120 mm. In at least one additional embodiment, the first and secondengaging components 12, 16 may have a width between 5 mm and 15 mm, andmay have a length between 30 mm and 200 mm, with any number of potentialwidths and lengths contemplated by the present disclosure suitable foruse with an exemplary restraining device 10 of the present disclosure.

In at least one embodiment of a restraining device 10 of the presentdisclosure, and as shown in FIG. 2, the first engaging component 12 ofthe restraining device 10 comprises a proximal end 13, a body having afirst side 12A and a second side 12B, and a distal end 14. The firstside 12A of the first engaging component 12 is configured to bepositioned adjacent to or in contact with a tissue or organ of interest.Likewise, the second engaging component 16 comprises a proximal end 17,a body having a first side 16A and a second side 16B, and a distal end18. The first side 16A of the second engaging component 16 is configuredto be positioned adjacent to or in contact with the tissue or organ ofinterest.

The first engaging component 12 and the second engaging component 16each comprise a material suitable to resist corrosion, such as andwithout limitation polyurethane, polyethylene, polytetrafluoroethylene(“PTFE”), nitinol, silastic, titanium, stainless steel or any othermaterial suitable for use in the medical arts that is corrosionresistant. Accordingly, the restraining device 10 can withstand chronicplacement within a body without the risk of deterioration. In at leastone embodiment, the first and second engaging components 12, 16 of therestraining device 10 are comprised of ultra high density polyethylene.

The first and second engaging components 12, 16 of the restrainingdevice 10 may be coupled to one or more springs 22, wherein the one ormore springs 22 engage the first and second engaging components 12, 16at their distal ends 14, 18 and proximal ends 13, 17. Springs 22, aswell as struts 700 (as shown in FIGS. 7A and 7B) and couplers 1200 (asshown in FIGS. 14A through 16B), as referenced herein, may be generallyreferred to as “connector(s)” as they connect, in various embodiments,first engaging components 12 and second engaging components 16 ofvarious restraining devices 10 of the present disclosure. The springs 22may comprise torsion springs or any other type of spring known ordeveloped that is capable of supporting the first and second engagingcomponents 12, 16 a prescribed distance apart from each other, which mayvary depending upon the orientation of the springs 22 about the firstand second engaging components 12, 16. As described in more detailherein, due to the configuration and resistance of the springs 22, thefirst and second engaging components 12, 16 of the restraining devicemay be held such that little or no space is defined between the firstsides 12A, 16A of the first and second engaging components 12, 16 basedupon a first orientation of springs 22, and the first and secondengaging components 12, 16 of the restraining device 10 may be held suchthat an interior space 70 is defined between the first sides 12A, 16A ofthe first and second engaging components 12, 16 based upon a secondorientation of springs 22.

Further, each of the one or more springs 22 may have any number of coilsconfigured in any fashion, provided the spring configuration andstiffness are suitable for the desired application of the restrainingdevice 10. For example, and without limitation, in at least oneembodiment each of the one or more springs 22 comprises a torsion,resistance spring having three (3) closely-coiled coils. It will beappreciated that, in practice, a clinician may alter the number of coilsand/or configuration of each spring 22 to achieve to a desiredflexibility or rigidity of the springs 22 and, in this manner, therestraining device 10 may be customized for a particular patient and/orapplication for which the restraining device 10 is to be applied.

Each of the springs 22 of the restraining device 10 may comprise atleast one rod 24 extending from each of the ends of its coils. Thelength of each rod 24 may be selected depending on the particularapplication for which the restraining device 10 is to be applied. Asshown in the exemplary embodiments of a restraining device 10 in FIGS. 1and 2, each rod 24 is coupled with either the first or second engagingcomponent 12, 16. For example, as shown in FIG. 2, the first rod 24 ofone of the springs 22 may be coupled with the second side 12B of thefirst engaging component 12 at or near a location on the distal end 14of the first engaging component 12, and the second rod 24 of the samespring 22 may be coupled with the second side 16B of the second engagingcomponent 16 at or near a location on the distal end 18 of the secondengaging component 16. Furthermore, the rods 24 facilitate the formationof the interior space 70 (as shown in FIG. 2) between the first andsecond engaging components 12, 16 by holding the first and secondengaging components 12, 16 in accordance with the tension of the springs22.

The springs 22 of the restraining device 10 may comprise any dimensionsso long as the restraining device 10 is of a sufficient size to movethrough a laparoscopic port and the springs 22 are capable of holdingthe first side 12A of the first engaging component 12 and the secondside 16A of the second engaging component 16 a distance apart when therestraining device 10 has a configuration whereby the springs 22 arepositioned about the first and second engaging components 12, 16. Forexample, springs 22 may have a “first” configuration as shown in FIG. 1,whereby springs 22 and the first and second engaging components 12, 16are oriented in the same or substantially the same direction/plane sothat the restraining device 10 may pass through a laparoscopic port. Insuch a first configuration, springs 22 engage the first and secondengaging components 12, 16 so that the first and second engagingcomponents 12, 16 either engage one another or have a relatively smallspace between them. Springs 22 may have a “second” configuration, forexample and as shown in FIG. 2, when springs 22 are rotated about firstand second engaging components 12, 16 and are not in the samedirection/plane as the configuration of restraining device shown inFIG. 1. In such a second configuration, the first and second engagingcomponents 12, 16 may define an interior space 70 when the restrainingdevice 10 is “at rest,” with the interior space 70 increasing uponpositioning the restraining device 10 around a stomach 100 (as shown inFIGS. 4A through 5A) for example, and potentially increasing onlyslightly further upon introduction of food, for example, into thestomach 100.

Accordingly, the dimensions of the springs 22 may dictate the nativevalue of the interior space 70 between the first and second engagingcomponents 12, 16. In at least one embodiment, the springs 22 maycomprise a maximum outside diameter that is less than about 14millimeters to allow a “collapsed” or “compressed” restraining device 10to pass within a 15 mm diameter abdominal port. Furthermore, each of thesprings 22 may comprise any material having a strength that is consonantwith the application for which the restraining device 10 will beemployed. In at least one embodiment, the springs 22 are comprised of arigid or semi-rigid material that is suitable to resist corrosion, suchas and without limitation, polyurethane, PTFE, nitinol, silastic,titanium, stainless steel or any other material suitable for use in themedical arts that is corrosion resistant.

Referring back to FIG. 2, and as previously described, the springs 22 ofthe restraining device 10 are biased to maintain the first and secondengaging components 12, 16 at a prescribed distance apart under anative, and as described above, “second” configuration. In this manner,when no pressure is applied to an exemplary restraining device 10—orwhen the restraining device 10 is “at rest”—the interior space 70 havinga prescribed value is formed between the first and second engagingcomponents 12, 16. The value of the interior space 70 may, in at leastone embodiment, correlate with the outside diameter of the springs 22,minus the thickness of the first and second engaging components 12, 16.It will be understood that the value of the interior space 70 can bemanipulated by a clinician depending on the thickness of tissue and/ororgan to be treated or other factors. For example, to achieve aninterior space 70 having a larger prescribed value, the outer diameterof the spring 22 may be increased and/or the thickness of the firstand/or second engaging components 12, 16 may be adjusted. Accordingly, aclinician can easily modify the restraining device 10 such that it maybe optimally configured for a particular application on a particulartissue.

Due to the nature of the springs 22 (depending on the material andrigidity selected), the first and second engaging components 12, 16 mayexhibit some degree of “give” such that the first and second engagingcomponents 12, 16 are capable of moving relative to each other whenpressure is applied. While the first and second engaging components 12,16 are biased to return to their resting position such that the interiorspace 70 is substantially equivalent to its prescribed/native value whenno pressure is applied to the springs 22, the springs 22 of therestraining device 10 are also capable of allowing the first and secondengaging components 12, 16 to move in response to force applied thereto.For example, and without limitation, if a force is applied against thefirst sides 12A, 16A of the first and second engaging components 12, 16,this force is translated to the springs 22 which enables the components12, 16 of the restraining device 10 to move apart such that the interiorspace 70 is increased. Furthermore, if a force is applied directly tothe springs 22 such that the coils are twisted about their axis in adirection counter to the coil configuration, similar to the above-listedexample, the resultant effect on the restraining device 10 is that thefirst and second engaging components 12, 16 are moved apart and theinterior space 70 is increased. However, due to the inherent biasprovided by the springs 22 of the restraining device 10, after thepressure affecting the springs 22 is released, the springs 22—and thusthe components 12, 16—return to their resting positions such that theinterior space 70 reverts to its original prescribed value. It will beappreciated that the specific configuration and/or materials comprisingeach of the springs 22 may be selected to achieve the desired degree ofelasticity depending on the application for which the restraining device10 is to be applied.

As shown in FIG. 2, each rod 24 of spring 22 is rotatably coupled withthe relevant component 12, 16 of the restraining device 10 such thateach of the rods 24 is capable of pivotal movement with respect to therelevant component 12, 16 of the restraining device 10. The rotationalcoupling of the rods 24 with the first and second engaging components12, 16 may be achieved through any means known in the art. For exampleand without limitation, the end of each rod 24 may comprise a pin thatis capable of insertion into and rotation within a hole formed withinthe respective second side 12B, 16B of the applicable component 12, 16.

As each of the rods 24 is coupled with a spring 22, when the rods 24rotate with respect to the components 12, 16, this effectively enablesthe respective spring 22 to move in an orbital manner with respect tothe proximal or distal end of the restraining device 10. Accordingly,the springs 22 are capable of rotating between a position that issubstantially parallel with the first and second engaging components 12,16 (as shown in FIG. 1, referred to as a “first” configuration herein)and a position that is substantially perpendicular to the first andsecond engaging components 12, 16 (as shown in FIG. 2, referred to as a“second” configuration).

The position of the springs 22 relative to the first and second engagingcomponents 12, 16 has the potential to significantly affect the overallwidth of the restraining device 10. For example and without limitation,when the springs 22 are positioned in the substantially perpendicularposition (i.e., a “second” configuration), the restraining device 10 mayhave a width that is more than twice the width of the same restrainingdevice 10 when its springs 22 are positioned in the substantiallyparallel position. Accordingly, the rotational coupling of the rods 24with the first and second engaging components 12, 16 provides aclinician with the ability to manipulate the overall width of therestraining device 10 during laparoscopic delivery and/or implantationand further enables the restraining device 10 to be applied to tissuesand/or organs having a length that is longer than the length of therestraining device 10 (as the proximal ends 13, 17 and the distal ends14,18 of the first and second engaging components 12, 16 of therestraining device 10 are not obstructed by the springs 22). In at leastone embodiment, the widest part of the restraining device 10 is lessthan about 15 millimeters when the springs 22 are in the substantiallyparallel position such that the restraining device 10 can be easilyinserted into a body cavity through a 15 millimeter trocar or port.

Now referring to FIG. 3A, a top view of at least one embodiment of arestraining device 10 of the present disclosure is shown. Here, thefirst and/or second engaging components 12, 16 of the restraining device10 further comprise one or more pads 30 extending therefrom. As shown inFIG. 3A, the one or more pads 30 may extend in a perpendicular fashionfrom the second side(s) 12B, 16B of the components 12, 16 and/or in alateral fashion from the components 12, 16. Each of the pads 30 arecomprised of a flexible material and configured to provide an anchorthrough which sutures or any other type of anchoring device may beinserted. For example, and in at least one embodiment, one or more pads30 may be comprised of polyurethane or any other material that iscapable of securely holding sutures or another type of anchoring devicetherein. One or more sutures may be placed within suture apertures 32 asshown in FIG. 3A, whereby said suture apertures 32 may be positionedalong pads 30 and/or one or both of components 12, 16 as shown in FIG.3A. Accordingly, after the first and second engaging components 12, 16are properly positioned about a targeted tissue or organ, sutures may beinserted through suture apertures 32 and secured to a superficial layerof the underlying targeted tissue or organ to assist in anchoring therestraining device 10 in the proper location thereon.

FIGS. 3B-3E show various embodiments of first engaging component 12and/or second engaging component 16 with various features to facilitatesuturing and/or connection of first engaging component 12 to secondengaging component 16. FIG. 3B shows an exemplary embodiment if a firstand/or second engaging component 12, 16 comprising suture apertures 32positioned therethrough. Suture apertures 32 are not limited topositioning near one or more of the ends of said first and/or secondengaging component 12, 16, as such suture apertures 32 may be positionedalong first and/or second engaging component 12, 16 as desired.

FIG. 3C shows an exemplary embodiment of a first and/or second engagingcomponent 12, 16 comprising one or more strings 34 affixed thereto. Inthe exemplary embodiment shown in FIG. 3C, two strings 34 are shown ator near the ends of first and/or second engaging component 12, 16,noting, however, that one, two, or more strings 34 may be affixedthereto and positioned as desired. In an exemplary embodiment of arestraining device 10, and as shown in FIG. 4B, the first engagingcomponent 12 and the second engaging component 16 may each comprise atleast one string 34, whereby said strings 34 may be connected to oneanother to facilitate a desired placement of restraining device 10 abouta stomach 100.

Additional embodiments of exemplary first and/or second engagingcomponents 12, 16 are shown in FIGS. 3D and 3E. As shown in FIG. 3D,first and/or second engaging component 12, 16 comprises one or moresuture members 36 affixed thereto, with said suture members defining anaperture to which a suture (not shown) or other restraining componentmay be affixed thereto. FIG. 3E shows an exemplary first and/or secondengaging component 12, 16 of the present disclosure comprising pads 30positioned at or near each end of the first and/or second engagingcomponent 12, 16 with each pad 30 defining a suture aperture 32therethrough. Additional embodiments of first and/or second engagingcomponent 12, 16 comprising features to allow for a suture or otherrestraining component to be positioned therethrough are alsocontemplated by the present disclosure. For purposes of the presentdisclosure, the term “suturing elements” shall mean any number ofelements for introducing a suture into the first and/or second engagingcomponent 12, 16 and/or one or more pads 30 affixed thereto, including,but not limited to, one or more apertures 32, strings, 34, and/or suturemembers 36. In addition, any number of the features of the variousexemplary first and/or second engaging components 12, 16 shown in FIGS.3A-3E may appear in any number of embodiments of restraining devices 10of the present disclosure.

In operation, the restraining device 10 may be applied to an organ ortissue of interest in order to restore the underlying tissue or organinto a desired configuration and/or provide support to the same. Asdiscussed in further detail below, the restraining device 10 may be usedfor temporary or chronic implantation within a body without the risk ofthe first and second engaging components 12, 16 migrating through ordamaging the underlying tissue. Furthermore, because the restrainingdevice 10 does not require that the underlying tissue be punctured inany significant manner to achieve restoration and/or provide supportthereto, implantation of the restraining device 10 is entirelyreversible and, if desired, the restraining device 10 may be easilyremoved from the organ or tissue of interest through a laparoscopicprocedure.

As previously described, the specifications of the restraining device 10may be modified to achieve a desired result. For example, and withoutlimitation, the dimensions of the components 12, 16 and/or the springs22 may be chosen for a particular application and/or based on thepatient. Accordingly, while certain embodiments of the restrainingdevice 10 may be described in connection with particular tissues ororgans, it will be appreciated that any of the embodiments of therestraining device 10 described herein may also be applied to any tissueor organ of interest in a similar manner and use of the particularembodiments of the restraining device 10 in lieu of others may bedetermined based on the patient's specifications, the specificapplication, and/or the tissue or organ in question.

In practice, an exemplary restraining device 10 is capable of restoringand/or supporting an underlying tissue while avoiding constriction andthe excessive compression thereof. For example, the restraining device10 may be applied to a stomach 100 as shown in FIGS. 4A and 4B. In atleast one embodiment, and as shown in FIG. 4A, the springs 22 of therestraining device 10 are rotated to the substantially perpendicularposition such that the interior space 70 is increased between the firstand second engaging components 12, 16. Thereafter, the restrainingdevice 10 may be advanced over the stomach 100 such that, for example,the first side 12A of the first engaging component 12 is positionedadjacent to the anterior wall of the stomach 100 and the first side 16Aof the second bar 16 is positioned adjacent to the posterior wall of thestomach 100. While the restraining device 10 is shown in FIG. 4A in alongitudinal placement with respect to the stomach 100, it will beunderstood that the restraining device 10 may alternatively bepositioned in a horizontal configuration or an angular configurationwith respect to the stomach 100.

After the first and second engaging components 12, 16 are positioned inthe desired location with respect to the stomach 100, the overallinterior space 70 may either comprise its original native interior space70 or a relatively larger interior space 70 due to the positioning ofthe restraining device 10 about the stomach 100. Therefore, variousembodiments of restraining device 10 do not operate to “clamp” thestomach 100 or any other tissue or organ, as restraining device 10merely operates, when positioned around a stomach 100, to provide alimited pressure, if any, to maintain a native size/shape of at least aportion of the stomach 100. For example, and depending upon theprescribed value of the interior space 70 as desired by a clinician, theconfiguration of the springs 22 can be modified to achieve a restrainingdevice 10 that either does not compress, or only loosely compresses, thesandwiched tissue between the first and second engaging components 12,16. In a preferred embodiment, restraining device 10, when positionedabout a stomach 100, does not provide any meaningful compressivepressure upon the stomach 100, and may be held in place, for example,using one or more sutures as referenced herein. In this manner, therestraining device 10 can be employed to reversibly restore an organ ortissue without forming adhesions thereon and/or permanently restoringthe same.

In at least one embodiment, and depending on the configuration of thesprings 22, the springs 22 may exhibit enough elasticity to enable thefirst and second engaging components 12, 16 to move to some degree inconjunction with any movement of a tissue or organ positioned betweenthe first and second engaging components 12, 16 of the restrainingdevice 10. In this manner, the springs 22 can allow, for example, therestraining device 10 to accommodate any inherent movement in thestomach 100 such that application of the restraining device 10 does notcompletely inhibit the normal digestive function of the same. Forexample, the introduction of food into the stomach 100 may cause theouter dimensions of the stomach 100 to expand, whereby stomach 100exerts a pressure upon restraining device 100. Furthermore, therestraining device's 10 ability to accommodate any inherent movement inthe underlying organ and/or tissue increases the likelihood that therestraining device 10 will remain in its desired location on the tissueand/or organ without sheering off or sliding therefrom.

In the event it is desired that the restraining device 10 is furthersecured to the underlying tissue, and as previously referenced herein, aclinician can employ sutures to assist with the secure implantation ofthe restraining device 10 in the desired location. In the at least oneembodiment of the restraining device 10 comprising the one or more pads30, a clinician can secure the one or more pads 30 of the first andsecond engaging components 12, 16 to the underlying tissue through theuse of superficial sutures. In this manner, the superficial sutures canbe affixed through the one or more pads 30 and the surface of theunderlying tissue such that the one or more pads 30 assist withanchoring the restraining device 10 in position on the tissue ofinterest. Conversely, and in at least one embodiment, sutures may beintroduced directly to the first and/or second engaging components 12,16 to secure a restraining device to a tissue or organ of interest asshown in FIGS. 3A-3E.

FIG. 4B shows a cross-sectional view of the stomach 100 of FIG. 4A takenalong A-A. As shown in FIG. 4B, when the first and second engagingcomponents 12, 16 of the restraining device 10 are longitudinallypositioned on the stomach 100, the stomach 100 is “divided” into twoportions—a first stomach portion 110 and a second stomach portion 112 asshown in FIGS. 4A and 4B. In the embodiment shown in FIGS. 4A and 4B,the first stomach portion 110 is relatively smaller than the secondstomach portion 112. However, and as shown in FIG. 5A, the first stomachportion 110 and the second stomach portion 112 may be approximately thesame size.

As the first stomach portion 110 receives ingested matter directly fromthe gastroesophageal junction 99 as shown in FIG. 4A, the placement ofthe restraining device 10 as shown in FIG. 4B thus inhibits the majorityof ingested matter from moving into the second stomach portion 112.Instead, and in at least one embodiment, such ingested matter isdirected through the smaller, first stomach portion 110 and into thepyloric canal 101 (as shown in FIG. 4A) where a significant portion ofthe ingested matter is evacuated from the stomach 100. Due to the sizeof the first stomach portion 110, the amount of food that the patientcan consume at one time is significantly reduced and satiety is morequickly achieved.

While the delineation formed by the restraining device 10 between thefirst stomach portion 110 and the second stomach portion 112 is notleak-proof, the interior space 70 created between the first and secondengaging components 12, 16 comprises an area that is less than thediameter of a fully extended stomach 100 (as shown in FIG. 4B).Accordingly, when the restraining device 10 is applied in a longitudinalfashion to a stomach 100, restraining device 10 provides support to theanterior and posterior walls of the stomach 100, with the expansion ofstomach 100 exerting a force onto the first and second engagingcomponents 12, 16 of restraining device 10, this preventing stomach 100distension in that area. In this manner, most of the food matterreceived into the first stomach portion 110 through the gastroesophagealjunction 99 is maintained therein and the patient exhibits the sensationof satiety earlier.

Referring back to FIG. 4A, and in at least one exemplary embodiment,because the restraining device 10 does not extend along the entirelength of the stomach 100, an outflow tract 114 is formed caudally ofthe restraining device 10. This outflow tract 114 allows the portion ofingested matter that flows from the gastroesophageal junction 99 intothe second stomach portion 112 to be evacuated from the stomach 100 in acontrolled manner and to proceed through normal digestion. In addition,the outflow tract 114 allows any food matter or enzymes residing withinthe second stomach portion 112 to evacuate the stomach 100.

Additional embodiments of restraining devices 10 of the disclosure ofthe present application positioned about a stomach 100 are shown inFIGS. 5B and 5C. In the exemplary embodiment shown in FIG. 5B,restraining device 10 comprises first and second engaging components 12,16 which are “longer” than those shown in FIG. 5A, whereby distal end 14of first engaging component 12 and distal end 18 of second engagingcomponent 16 extend past stomach 100. In this exemplary embodiment,strings 34 affixed to first and second engaging components 12, 16 may beconnected/tied to each other after restraining device 10 has beenpositioned about a stomach, maintaining restraining device 10 in place.

FIG. 5C shows restraining device 10 positioned about stomach 100 viewedin the direction of the arrow shown in FIG. 5B. As shown in FIG. 5B, thetying/coupling together of strings 34 at the distal ends 14, 18 of firstand second engaging components 12, 16 may cause portions of the firstand second engaging components 12, 16 to angle towards one another asshown in FIG. 5C. In this particular embodiment, first and secondengaging components 12, 16 are flexible or semi-flexible, and thepositioning of restraining device 10 about stomach 100 serves to isolatethe first stomach portion 110 from fundus 90 and greater curvature 92.This “funnel” effect, in addition to the embodiment of a restrainingdevice 10 shown in FIG. 5D below, may also be accomplished by havingsprings 22 with relatively shorter rods 24 (or relatively smaller struts700 as referenced in various embodiments herein) at one end ofrestraining device 10, and by having springs 22 with relatively longerrods 24 (or relatively larger struts 700 as referenced in variousembodiments herein) at the other end of restraining device 10. Inaddition as to being substantially rigid as shown in FIGS. 1 and 2, andas shown in FIG. 5C, first and second engaging components 12, 16 mayhave substantially rigid center portions and one or more flexible orsemi-flexible ends, or first and second engaging components 12, 16 maybe flexible or semi-flexible along the entirety of said components 12,16.

An additional embodiment of a restraining device 10 of the presentdisclosure positioned about stomach 100 is shown in FIG. 5D. As shown inFIG. 5D, and as also discussed herein regarding FIG. 10, restrainingdevice 10 further comprises a pliable junction 1000 positioned withinthe first engaging component 12 and second engaging component 16,effectively “splitting” each component, whereby each “split” componentis connected to one another by way of a flexible structure 1002. Asshown in FIG. 5D, flexible structure 1002 may comprise a PTFE band or aPTFE mesh, for example, whereby any potential embodiment of flexiblestructure 1002, using one or more pliable materials disclosed herein orotherwise known in the art, allows the relatively or fully rigid firstengaging component 12 and second engaging component 16 to better fit thestomach, allowing the patient, for example, to bend the stomach whenrestraining device 10 is positioned thereon.

Approximating first and second engaging components 12, 16, as shown inFIGS. 5B, 5C, and 5D, and as identified during internal testing ofexemplary restraining devices 10 of the present disclosure, leads toreduced food intake (65-70% of normal food intake) as compared topositioning restraining device 10 about stomach 100 withoutapproximating first and second engaging components 12, 16 toward oneanother as shown in FIG. 4A (80-85% of normal food intake). Thisapproximation also assists with the prevention of a fistula so that thefood may move down the pouch (first stomach portion 110) along antrum 94as opposed to shunted to the fundus 90 of stomach 100.

As described herein, application of the restraining device 10 allows aclinician to restore a targeted tissue, such as a stomach 100, whileavoiding constriction and excessive compression of the same. Further,the various embodiments described herein allow a clinician to tailor therestraining device 10 to multiple restoration applications and variousdifferent types of tissues. Permanent restoration of the tissue isavoided, which prevents adhesions from developing in the underlyingtargeted tissue and allow for the complete reversal of the restorationprocedure. Additionally, the restraining device 10 is simple to deliverand, as such, the device 10 may be used in conjunction with othertechniques or surgical procedures.

Regarding the application of the restraining device 10 to the stomach100, use of the restraining device 10 in the treatment of obesity avoidsthe nutritional and metabolic deficiencies observed after MalabsorptiveProcedures because the digestive process may continue within the stomachas with a native stomach 100. In addition, the restraining device 10does not require more than superficial punctures to the underlyingtissue, nor does it employ pins, staples or significant sutures whichmay lead to dehiscence or fistula formation, or produce the degree ofregurgitation and vomiting observed in connection with conventionalmethods used to treat obesity. Moreover, each of the embodimentsdescribed herein may be inserted into the body cavity laparoscopically,thereby decreasing the patient's stress associated with the procedureand the patient's recovery time. It will be recognized that any of thedevices described herein may be employed in combination with otherconventional bariatric procedures.

Now referring to FIG. 6, a flow chart of a method 300 forlaparoscopically delivering the restraining device 10 is shown. For easeof understanding, the steps of the related methods described herein willbe discussed relative to the components of an exemplary restrainingdevice 10. Furthermore, while the methods described herein are describedin connection with embodiments of the restraining device 10 and anexemplary delivery device, it will be appreciated that variousadditional devices may be used to facilitate the laparoscopic deliveryof the restraining device 10 such as a camera, light and/or a device fordelivering a gas to a targeted area.

At step 302, the first and second engaging components 12, 16 ofrestraining device 10 are advanced laparoscopically into the patient'sbody. In at least one embodiment, the restraining device 10 may beinserted through a 15 millimeter cannula under insufflation into theappropriate cavity of the patient's body. This may be achieved throughuse of an exemplary delivery device known in the art. At this step 302,the springs 22 of the restraining device 10 are positioned in thesubstantially parallel position such that the overall diameter of therestraining device 10 is sufficiently narrow for insertion into thebody.

At step 304 the restraining device 10 is advanced to a location adjacentto a targeted tissue. In the at least one embodiment of the method 300where an exemplary delivery device is employed to facilitate delivery ofthe restraining device 10 to the targeted tissue, at step 304 therestraining device 10 is advanced out of the delivery device and intothe body cavity. After the restraining device 10 is no longer positionedwithin an exemplary delivery device, the delivery device may bewithdrawn from the body cavity at this step 304 or as desired by theclinician.

At step 306, the springs 22 of the restraining device 10 are rotatedfrom the substantially parallel position to the substantiallyperpendicular position, separating the first and second engagingcomponents 12, 16 from one another to a native interior space 70. Step306 may be performed using any number of standard laparoscopic toolsknown in the art useful to pull and grasp portions of a tissue or adevice. In this manner, neither the proximal ends 13, 17 nor distal ends14, 18 of the first and second engaging components 12, 16 of therestraining device 10 are blocked by the springs 22 and/or rods 24, andthe first and second engaging components 12, 16 may be advanced over atargeted tissue having a length that is greater than the overall lengthof the first and second engaging components 12, 16.

At step 308, under fluoroscopic, direct camera control or otherwise, therestraining device 10 is advanced over the targeted tissue. In at leastone embodiment, and at step 308, the first side 12A of the firstengaging component 12 is positioned adjacent to the desired surface ofthe targeted tissue and the first side 16A of the second engagingcomponent 16 is positioned adjacent to an opposite side of the targetedtissue. As the first and second engaging components 12, 16 of therestraining device 10 are positioned adjacent to opposite sides of thetargeted tissue, at this step 308 the targeted tissue is positionedwithin the interior space 70 formed between the first and secondengaging components 12, 16. Accordingly, while the targeted tissue mayexperience some compressional force exerted by the first and secondengaging components 12, 16 of the restraining device 10, the majority ofthe pressure upon the first and second engaging components 12, 16 isprovided by distension/expansion of the targeted tissue (for example,expansion of a stomach 100 when food is introduced therein). Further,due to the configuration and composition of the restraining device 10,the restraining device 10 can remain within the patient's body for aslong as the restoration or support treatment delivered thereby isdesired.

If preferred, in at least one embodiment of the restraining device 10that further comprises one or more pads 30 coupled with the first and/orsecond engaging components 12, 16, the method 300 may advance from step308 to step 310. At step 310, a clinician can employ sutures to furtheranchor and secure the restraining device 10 in the desired position onthe targeted tissue. These sutures need only superficially puncture theunderlying tissue and therefore are not associated with the negativeeffects associated with suturing, stapling and/or the insertion of pinsused in conventional methods.

Additional embodiments of restraining devices 10 of the disclosure ofthe present application is shown in FIGS. 7A and 7B. As shown in FIGS.7A and 7B, restraining device 10 comprises a first engaging component 12and a second engaging component 16, whereby the first engaging component12 and second engaging component 16 are coupled to one another by way ofone or more struts 700. In the exemplary embodiment shown in FIGS. 7Aand 7B, four struts 700 and five struts 700 are used, respectively, butany number of struts 700 may be used as desired for a particularapplication. Struts 700 may comprise any number of suitable materials asotherwise described herein, including, but not limited to, nitinol andstainless steel. Struts 700, in an exemplary application, would have apre-established “open” size and a pre-established “strength”, so thatrestraining device, in a native “rest” configuration, would be “open”(by way of, for example, the “memory” of struts 700) and would requiresome sort of pressure/force to open even further. The “open”configuration would keep first engaging component 12 and second engagingcomponent 16 a fixed distance apart to avoid gastric tissue compressionwhen positioned about a stomach.

An exemplary restraining device 10 may further comprise a mesh curtain702 coupled to struts 700 as shown in FIGS. 7A and 7B. Mesh curtain 702may prevent or limit potential organ distension or remodeling whenrestraining device 10 is positioned about an organ of interest. A demishaft 704, as shown in FIGS. 7A and 7B, may be positioned around atleast part of struts 700 and/or mesh curtain 702 to facilitate insertionof restraining device 10 within a body. For example, and as shown inFIG. 7A, restraining device 10 may be seen as inserted within a body,noting that restraining device is somewhat compressed by demi shaft 704,to facilitate insertion through, for example, a laparoscopic port. Afterinsertion, and as shown in FIG. 7B, demi shaft 704 may be withdrawn inthe direction of the arrow (shown as partially withdrawn in the figure)to allow restraining device 10 to obtain its original, uncompressedconfiguration, and ultimately removed from the body. Struts 702 may havea first configuration when positioned within demi shaft 704, as shown inFIG. 7A, and may have a second configuration when demi shaft 704 isremoved, as shown on the left side of FIG. 7B.

When restraining device 10 is in its native configuration, it may thenbe positioned about a stomach, for example, and the user positioningrestraining device 10 may grasp stomach tissue using any number oflaparoscopic tools through mesh aperture 706 as shown in FIGS. 7B and 8.As shown in FIG. 8, an exemplary restraining device 10 may also compriseone or more suture members 36 to allow one or more sutures (not shown)to be used to secure restraining device 10 to, for example, an anteriorgastric wall.

An additional embodiment of a restraining device 10 of the disclosure ofthe present application is shown in FIG. 9. As shown in FIG. 9,restraining device 10 comprises a first engaging component 12 and asecond engaging component 16, whereby first engaging component 12 andsecond engaging component 16 are coupled to one another by way of one ormore springs 22. In this exemplary embodiment, restraining device 10further comprises a mesh curtain 702 coupled to first engaging component12 and second engaging component 16, whereby mesh curtain 702 mayprevent or reduce organ distension or remodeling when restraining device10 is positioned about an organ. The flexibility/pliability of meshcurtain 702 would allow mesh curtain 702 to be closely positioned firstengaging component 12 and second engaging component 16 upon insertion ofrestraining device 10 within a body, and may further allow mesh curtain702 to expand in a direction of springs 22 as shown in FIG. 9, forexample, to prevent organ distention.

FIG. 10 shows yet another embodiment of a restraining device 10 of thepresent application. As shown in FIG. 10, restraining device comprises afirst engaging component 12 and a second engaging component 16, wherebyfirst engaging component 12 and second engaging component 16 are coupledto one another by way of one or more springs 22. However, in thisexemplary embodiment, restraining device 10 further comprises a pliablejunction 1000 positioned within the first engaging component 12 andsecond engaging component 16, effectively “splitting” each component,whereby each “split” component is connected to one another by way of aflexible structure 1002. As shown in FIG. 10, flexible structure 1002may comprise a PTFE band or a PTFE mesh, for example, whereby anypotential embodiment of flexible structure 1002, using one or morepliable materials disclosed herein or otherwise known in the art, allowsthe relatively or fully rigid first engaging component 12 and secondengaging component 16 to better fit the stomach, allowing the patient,for example, to bend the stomach when restraining device 10 ispositioned thereon. In addition, and as shown in the exemplaryembodiment in FIG. 10, restraining device 10 may further comprise atissue cover 1004 positioned either partially or fully around either orboth of first engaging component 12 and second engaging component 16.

FIG. 11 shows an exemplary embodiment of a restraining device 10 of thepresent application positioned within a laparoscopic port. As shown inFIG. 11, restraining device 10 is shown as being inserted into a bodyportion by way of laparoscopic port 1100, with the exemplarylaparoscopic port 1100 shown as comprising a ring 1102 and a port sleeve1104 to facilitate introduction of restraining device 10 through anabdominal wall 1106. Viewing the figure from the outside-in, restrainingdevice 10 is shown as being introduced into an abdomen through abdominalwall 1106, with peritoneum 1108 shown as being an innermost layer of theabdominal wall.

An additional embodiment of a restraining device 10 of the disclosure ofthe present application is shown in FIG. 12A. As shown in FIG. 12A,restraining device 10 comprises a first engaging component 12 and asecond engaging component 16, whereby first engaging component 12 andsecond engaging component 16 are coupled to one another by way of one ormore couplers 1200. In this exemplary embodiment, restraining devicecomprises two couplers 1200, shown in further detail in FIG. 12B.Couplers 1200 may comprise coupler arms 1202 connected to one another byway of a coupler bar 1204, and may comprise any number of suitablematerials as described herein for various components of the presentdisclosure. As shown in FIG. 12A, coupler arms 1202 may be positionedwithin first engaging component 12 and second engaging component 16 byway of apertures 1210 (as shown in FIG. 12B) defined therein, allowingfirst engaging component 12 and second engaging component 16 to moverelative to one another as couplers 1200 swivel when positioned at leastpartially within said apertures 1210.

As shown in FIG. 12B, an exemplary embodiment of a coupler 1200 maycomprise a coupler protrusion 1206 at or near the end of each couplerarm 1202, whereby coupler protrusions either prevent or restrict theremoval of coupler 1200 from the either first engaging component 12 orthe second engaging component 16 by way of stops 1208 positioned aboutthe first engaging component 12 and the second engaging component 16 ator near the apertures 1210 defined therein. As coupler 1200 moves in thedirection of the arrow shown in FIG. 12B, coupler protrusions 1206 wouldengage stops 1208, thus preventing or restricting the removal of coupler1200 from the first engaging component 12 and/or the second engagingcomponent 16.

Insertion of the exemplary embodiment of the restraining device 10 shownin FIG. 12A into a body portion may be performed by inserting saidrestraining device 10 through a laparoscopic port with first engagingcomponent 12 and second engaging component 16 either touching or nearlytouching one another, and with couplers 1200 either mostly or fullyinserted within apertures 1210 of restraining device 10. Whenrestraining device has been inserted into a body portion, first engagingcomponent 12 and second engaging component 16 may be separated apre-established distance from one another my way of turning/swivelingcouplers 1200. As such, couplers 1200, as well as first engagingcomponent 12 and second engaging component 16, may be sized and shapedas desired for a particular application,

FIGS. 13A and 13B show an exemplary embodiment of a restraining device10 with a coupler 1200 positioned therein in a configuration to maximizethe interior space 70 between first engaging component 12 and secondengaging component 16. As such, the configuration of coupler 1200 shownin FIG. 12A may be viewed as “closed,” while the configuration shown inFIG. 13A may be viewed as “open.” In addition, and as described aboveand shown in FIG. 13A, coupler 1200 may be withdrawn from apertures offirst engaging component 12 and second engaging component 16 tofacilitate placement of restraining device about an organ of interest,Such withdrawal may be performed using any number of laparoscopic tools,for example, whereby coupler 1200 is withdrawn up to a point whereprotrusions 1206 would engage stops 1208 as shown in FIG. 12B.

Another exemplary embodiment of a restraining device 10 of thedisclosure of the present application is shown in FIGS. 14A and 14B. Asshown in FIGS. 14A and 14B, restraining device 10 comprises a firstengaging component 12 and a second engaging component 16, whereby firstengaging component 12 and second engaging component 16 are coupled toone another by way of one or more couplers 1200. In the embodimentsshown in FIGS. 14A and 14B, couplers 1200 comprise “scissor” couplers1200, whereby at least two coupler bars 1204 are connected to oneanother via a pivot member 1400 so that coupler bars 1204 may pivotabout one another at pivot member 1400. As coupler 1200 shifts from a“closed” configuration, as shown in FIG. 14A, to an “open”configuration, as shown in FIG. 14B, coupler bars 1204 pivot about pivotmember 1400 causing coupler bars 1204 to move closer to one another in adirection opposite the direction of the length of first engagingcomponent 12 and second engaging component 16.

Couplers 1200, as shown in FIGS. 14A and 14B, may “open” and “close” byway of movement of coupler arms 1202 (ends shown in the two figures)within apertures 1210 defined within first engaging component 12 andsecond engaging component 16. Apertures 1210, as shown in theseexemplary embodiments, are configured as horizontal grooves to allowcoupler arms 1202 to move closer to one another within the same aperture1210 while coupler 1200 is “opening” and to allow coupler arms 1202 tomove away from one another within the same aperture 1210 while coupler1200 is “closing.” As shown in FIG. 14B, restraining device 10, in afully open position, would maximize the interior space 70 between firstengaging component 12 and second engaging component 16. Protrusions1402, such as teeth, indentations, and the like, may be positioned at ornear apertures 1210, as shown in FIG. 14B, to facilitate fixation ofcoupler arms 1202 in a desired position, allowing a user positioningrestraining device 10 within a body to measure the exact the interiorspace 70 between first engaging component 12 and second engagingcomponent 16.

Upon insertion of the exemplary embodiment of restraining device 10shown in FIGS. 14A and 14B within an abdominal cavity (through alaparoscopic port, for example), any number of laparoscopic tools may beused to grasp couplers 1200 to withdraw them from first engagingcomponent 12 and second engaging component 16 as referenced hereinregarding various other embodiments of restraining devices 10.

An exemplary delivery apparatus for delivering a restraining device 10of the present application is shown in FIGS. 15A and 15B. As shown inFIG. 15A, an exemplary delivery apparatus 1500 comprises a shaft 1502and arms 1504 at or near a distal end 1506 of shaft 1502. Apparatus 1500may further comprise string 1508, whereby string 1508 may either becoupled to or engaged by a pull bar 1510 (an exemplary “puller” of thepresent disclosure) positioned within the lumen of apparatus 1500. Arms1504 may engage an outer surface of first engaging component 12 andsecond engaging component 16, a protrusion (not shown) extending fromsaid components, or by way of a groove 1512 (shown in FIG. 15B)positioned within said components.

As shown in FIG. 15A, string 1508 is coupled to springs 22 ofrestraining device 10, whereby a “pulling” motion of pull bar mayeffectively pull springs 22 from a first configuration (not shown inFIG. 15A) to a second configuration as shown in FIG. 15A so thatrestraining device may be positioned about an organ of interest. In anadditional embodiment, string 1508 may be positioned at least partiallywithin the lumen of apparatus 1500, whereby a user of apparatus may pullstring 1508 instead of pulling pull bar 1510 to operate apparatus 1500.Various components of apparatus 1500 may comprise any number of suitablematerials, including, but not limited to, the various materialsreferenced herein in connection with components of restraining device10. For example, string 1508 may comprise, for example, plastic or metalthread.

For example, and in an abdominal cavity with the epiplon lessercurvature dissected, arms 1504 of apparatus 1500 may positionrestraining device 10 to a desired location, springs 22 of restrainingdevice 10 may be widely opened, thus separating the first engagingcomponent 12 and the second engaging component 16 by using pull bar 1510to pull the strings 1508 and move springs 22 from an axial position to a90.degree. position relative to first engaging component 12 and thesecond engaging component. An “opened” restraining device 10 may then beintroduced through the dissected lesser curvature space in parallelposition to the intragastric mannequin tube, thus creating a desiredpouch size. First engaging component 12 and second engaging component16, upon positioning restraining device 10 about a stomach, would occupythe anterior and posterior wall of the stomach. When the first engagingcomponent 12 and the second engaging component 16 are located in thedesired position, spring 22 approximates the first engaging component 12and the second engaging component 16 to each other gradually withoutproducing any ischemic or tissue damage. Upon moving springs 22 to theirdesired location and/or positioning restraining device 10 about thestomach, restraining device 10 is separated from apparatus 1500, strings1508 are cut and apparatus 1500 is pulled out of the abdominal cavitythrough the port. Restraining device 10 may then be secured in thegastric tissue with superficial stitches.

FIG. 15B shows an exemplary embodiment of at least a portion ofapparatus 1500 engaging a “closed” restraining device 10. As shown inFIG. 15B, arms 1504 of apparatus 1500 are shown engaging first engagingcomponent 12 and second engaging component 16 of restraining device 10by way of grooves 1512 positioned within said components, permittingapparatus 1500 to deliver restraining device 10 through an abdominalport.

FIGS. 16A and 16B show an exemplary embodiment of an apparatus 1500engaging/positioning an exemplary restraining device 10 of thedisclosure of the present application. As shown in FIGS. 16A and 16B,arms 1504 of apparatus 1500 may engage the first engaging component 12and the second engaging component 16 of restraining device 10, wherebythe “opening” of arms 1504 would facilitate the “opening” of restrainingdevice from a “closed” configuration (as shown in FIG. 16A) to an “open”configuration (as shown in FIG. 16B).

“Opening” restraining device 10, as shown in FIG. 16B, may be performedas follows. In the abdominal cavity with the epiplon lesser curvaturedissected, the arms 1504 of apparatus 1500 may be widely opened, thusseparating the first engaging component 12 and the second engagingcomponent 16 of restraining device 10. A surgeon, for example and withthe aid of laparoscopic graspers, may then “pull” out couplers 1200,placing couplers 1200 in a withdrawn configuration as shown in FIG. 16B.Restraining device 10, in an “open” configuration, may be introducedthrough the dissected lesser curvature space in parallel position to theintragastric mannequin tube, thus creating the desired stomach pouchsize. First engaging component 12 and second engaging component 16, whenpositioned about a stomach, would occupy the anterior and posterior wallof the stomach. When the first engaging component 12 and the secondengaging component 16 are located in the desired position, theuser/operator may then approximate the plates to each other gradually(millimetrically) using apparatus 1500 device without producing anyischemic or tissue damage. When the user/operator has positionedrestraining device 10, apparatus 1500 would then be separated fromrestraining device and pulled out of the abdominal cavity through theport. If desired, restraining device may also be secured in the gastrictissue with superficial stitches.

FIGS. 17A and 17B show another exemplary embodiment of an apparatus 1500engaging/positioning an exemplary restraining device 10 of thedisclosure of the present application. As shown in FIGS. 17A and 17B,arms 1504 of apparatus 1500 may engage the first engaging component 12and the second engaging component 16 of restraining device 10, wherebythe use of string 1508 connected to the first engaging component 12 andthe second engaging component 16 may be used by an operator of apparatus1500 to “open” and/or “close” said components. One or more strings 1508,in such exemplary embodiments, may be coupled at their first ends to thefirst engaging component 12 and/or the second engaging component 16, andmay be coupled at their second ends to a string rotator 1700 (anotherexemplary “puller” of the present disclosure) as shown in FIGS. 17A and17B. Operation/rotation of string rotator 1700 may then facilitate the“opening” of restraining device 10 from a “closed” configuration (asshown in FIG. 17A) to an “open” configuration (as shown in FIG. 17B). Insuch an embodiment, arms 1504 may also be positioned upon the firstengaging component 12 and/or the second engaging component 16 at or nearthe center of said components (forming a “pivot” area), and the stringrotator 1700 and strings 1504 affixed thereto may operate to keep saidcomponents in their axial position. Ultimate restraining device 10delivery may be performed using one or more methods described herein.

Restraining device 10 may also be positioned “perpendicularly” usingapparatus 1500 as shown in FIG. 18. As shown in FIG. 18, arms 1504 andstrings 1508 are shown positioned about the first engaging component 12and the second engaging component 16 “perpendicularly” so thatrestraining device 10 and apparatus 1500 are not aligned with oneanother. Rotation of string rotator 1700, as described above, mayfacilitate the opening and/or closing of restraining device 10.

The various embodiments of restraining devices 10 of the presentdisclosure may be introduced into a body cavity through, for example, alaparoscopic port. Such restraining devices 10 would be inserted while“compressed” (as shown in FIGS. 1, 7A, 10, 11, 12A, and 14A, forexample), and when inserted, would be “opened” or “deployed” (as shownin FIGS. 2, 7B, 8, 9, 13A, 13B, and 14B, for example) prior to beingpositioned about a stomach 100. In addition, a user of such arestraining device 10 may adjust the opening/deployed dimensions ofrestraining device 10 prior to positioning it about a stomach, and mayfurther tailor the open/deployed dimensions of restraining device 10after it has been positioned as desired.

Furthermore, any number of exemplary embodiments of restraining devices10 of the present application may be wholly or partially resorbable bythe body. For example, and using the exemplary restraining device 10shown in FIGS. 1 and 2 as an example, first and second engagingcomponents 12, 16 may not be resorbable by the body, while springs 22may be resorbable. In such an embodiment, restraining device 10, oncepositioned about a stomach 100, may slowly begin the process of total orpartial resorption. Resorbable materials suitable for one or moreportions of restraining devices 10 may include, but are not limited to,polyglycolide (PGA), polylactide (PLA), l-lactide (LPLA),poly(dl-lactide) (DLPLA), poly(.epsilon.-caprolactone) (PCL),poly(dioxanone) (PDO), polylglycolide-trimethylene carbonate (PGA-TMC),poly(d,l-lactide-co-glycolide) (DLPLG), or combinations thereof.

In a situation where it is desired to have restraining device 10 serveas a reversible bariatric device, and if it is desired not to engage ina subsequent procedure to, for example, laparoscopically remove some orall of restraining device 10 from a body, some or all of restrainingdevice 10 may be resorbed. By way of example, an exemplary restrainingdevice comprising resorbable springs 22 may be positioned about astomach, and first and second engaging components 12, 16 may slowlybecome coated with various fibrotic tissue. As springs 22 resorb,springs 22 will eventually no longer operate to connect first and secondengaging components 12, 16 to one another, which will effectively causethe various portions of restraining device 10 to no longer serve as arestraining mechanism. Springs 22 may also become coated, in part or intheir entirety, by fibrotic tissue, so that when springs 22 resorb,first and second engaging components 12, 16 remain positioned aboutstomach 100, but the introduction of food into a stomach 100, forexample, does not exert any pressure on springs 22 by way of first andsecond engaging components 12, 16 as first and second engagingcomponents 12, 16 are no longer connected to one another by way ofsprings 22. Furthermore, first and second engaging components 12, 16 maybe resorbable and springs 22 may not, so as first and second engagingcomponents 12, 16 resorb within the body, springs 22 no longer serve toconnect first and second engaging components 12, 16 to each other, andrestraining device 10 no longer performs any restraining function.Additional embodiments of restraining devices 10 may be resorbable,including, but not limited to, struts 700 and mesh curtain 702.

Regarding removal of exemplary embodiments of restraining devices 10 ofthe present application, said restraining devices 10 may be removed inwhole or in part, for example, by way of a laparoscopic procedure.Reversibility of restraining devices 10, as referenced in the presentapplication, pertains to the ability to position a restraining device 10about a tissue or organ, and at some time thereafter, have some or allof restraining device 10 resorb within a body or remove some or all ofrestraining device from the body so that restraining device 10 no longerfunctions to restrain a tissue or organ. For example, and referencingthe exemplary embodiments shown in FIGS. 1 and 2, a laparoscopicprocedure to remove springs 22 from the restraining device 10 and thebody, but not to remove first and second engaging components 12, 16 fromthe body, would have the effect of “reversing” the procedure of placingsaid restraining device 10 about a tissue or organ. Similarly, and asshown in FIGS. 7A, 7B, and 8, removal of struts 700 from restrainingdevice 10 would also have the effect of “reversing” the placement ofrestraining device 10 about a tissue or organ.

Furthermore, and if desired, the entirety of restraining device 10 maybe removed laparoscopically by, for example, reversing the steps used toinsert said restraining device 10 within a body. For example, a method1900 for removing a restraining device 10 from a body as shown in FIG.19 may comprise the steps of withdrawing restraining device 10 from atissue or organ (withdrawal step 1904), configuring restraining device10 to fit within a laparoscopic port (configuration step 1906), andremoving restraining device 10 from the body through a laparoscopic port(removal step 1908). Such an exemplary method may be preceded bypositioning a laparoscopic port within a body to facilitate removal ofrestraining device 10 (port insertion step 1902), and may be followed byremoving said laparoscopic port from the body after removal step 1908(port removal step 1910).

Additional embodiments of restraining devices 10 of the presentdisclosure are shown in FIGS. 20 and 23. As shown in the embodimentsshown in FIGS. 20 and 23, restraining devices 10 comprise a firstengaging component 12 and a second engaging component 16, such as thoseprovided in various other embodiments herein. First engaging component12 and second engaging component 16, in such an exemplary embodiment,are positioned relatively parallel to one another. A first swivel arm2000 and a second swivel arm 2002 are pivotally connected to firstengaging component 12 and second engaging component 16, so that firstswivel arm 2000 engages first engaging component 12 at pivot point 2004and engages second engaging component 16 at pivot point 2006, and sothat second swivel arm 2002 engages first engaging component 12 at pivotpoint 2008 and engages second engaging component 16 at pivot point 2010.First swivel arm 2000 and second swivel arm 2002 may swivel in thedirections shown in arrows A and B in FIGS. 20 and 23, noting that firstswivel arm 2000 and second swivel arm 2002 may move in oppositedirections, so that one moves in the direction of arrow A and the othermoves in the direction of arrow B, or first swivel arm 2000 and secondswivel arm 2002 may move in the same direction.

First engaging component 12 and/or second engaging component 16 maypresent studs 2012, as shown in FIGS. 20 and 23, whereby studs 2012permit first swivel arm 2000 and/or second swivel arm 2002 to be engagedthereto and permit swiveling/rotation about the various pivot points. Inat least one embodiment, studs 2012 have a bulbous component relativelylarger than a non-bulbous portion, so that a first swivel arm 2000and/or a second swivel arm 2002 presenting one or more apertures 2014therethrough may engage studs 2012. Any number of other means to couplefirst swivel arm 2000 and/or second swivel arm 2002 to first engagingcomponent 12 and/or second engaging component 16 may be used, such aspins, rivets, snaps, screws, and/or other fasteners or coupling means.

First swivel arm 2000 and second swivel arm 2002, as shown in FIGS. 20and 23, may further comprise a first interconnection arm 2016 and asecond interconnection arm 2018 positioned relative to bends 2020, 2022of said arms. Bends 2020, 2022, as shown in FIGS. 20 and 23, arepositioned in the relative middle (somewhere between the relative ends)of first swivel arm 2000 and a second swivel arm 2002, so that firstswivel arm 2000 and second swivel arm 2002 form a relative “U-shape”within restraining device 10. First swivel arm 2000 and/or a secondswivel arm 2002 may further comprise various additional curvatures 2024,such as shown in FIG. 20, such that bends 2020, 2022 and/or curvatures2024 define a native U-shaped configuration as previously described.

An interior space 70 between the first engaging component 12 and thesecond engaging components 16, as shown in FIGS. 20 and 23, may changedepending on various factors and/or configurations of restraining device10. For example, and during insertion of an embodiment of a restrainingdevice 10 such as shown in FIG. 20 or 23 through a laparoscopic port,first swivel arm 2000 and a second swivel arm 2002 may be relativelyparallel to, or in the same relative plane as, first engaging component12 and second engaging component 16, so that the interior space 70 isrelatively small. After insertion, and after swiveling first swivel arm2000 and a second swivel arm 2002 about first engaging component 12 andsecond engaging components 16, the interior space 70 may either stay thesame or increase to facilitate placement of restraining device 10 abouta stomach, for example. Furthermore, the use of a tape 2026 positionedabout one or more of the first swivel arm 2000 and the second swivel arm2002, as shown in FIG. 20, may further adjust the amount of interiorspace 70 between the first engaging component 12 and the second engagingcomponents 16 depending on the amount of relative tension (pull) isapplied to tape 2026. For example, if tape 2026 is positioned about oneor more of the first swivel arm 2000, and the second swivel arm 2002 sothat pulling tape 2026 in a direction shown by arrow C in FIG. 20 causesportions of tape 2026 to press against first interconnection arm 2016and/or second interconnection arm 2018 causing the relative ends of eachof first swivel arm 2000 and a second swivel arm 2002 to move towardeach other, the amount of interior space 70 between first engagingcomponent 12 and second engaging component 16 may be reduced. In such anembodiment, restraining device 10 could be inserted into a mammalianbody, positioned around a bodily organ without applying pressure to saidorgan, and tape 2026 could be pulled so that the amount of interiorspace 70 is adjusted as desired for the particular application. In abariatric application, for example, it is desired not to have portionsof restrictive device 10 apply any pressure about the stomach, but tape2026 could be pulled/adjusted so first engaging component 12 and secondengaging component 16 properly engage the stomach and be sutured theretoas desired. Distention of the stomach, such as by the introduction ofsolid and/or liquid food or water into the stomach, would cause thestomach to exert a force/pressure against the first engaging component12 and second engaging component 16, forming a first stomach portion 110and a second stomach portion 112 as shown in FIGS. 4A and 4B referencedabove and FIG. 21 referenced below.

In addition, and as shown in the exemplary embodiments of restrainingdevices 10 of the present disclosure shown in FIGS. 20 and 23, variousportions of restraining device 10, such as the first engaging component12, the second engaging component 16, the first swivel arm 2000, and/orthe second swivel arm 2002 may have one or more suture apertures 32defined therethrough to facilitate the placement of one or more sutures34 (also referred to herein as strings 34) to couple restraining device10 to a portion of a mammalian body, such as a stomach. In variousembodiments, one or more of the relative ends of the first engagingcomponent 12 and the second engaging component 16 may be rounded and/ortapered to improve overall patient comfort when a restraining device ispositioned within the patient's body.

FIG. 21 shows an exemplary embodiment of a restraining device 10, suchas shown in FIG. 20, positioned about a stomach. As shown in FIG. 21,device 10 may be positioned about stomach 100 similar to placement ofrestraining device 10 about stomach 100 as shown in FIG. 5B, so that thefirst engaging component 12 and the second engaging component 16 (notshown in FIG. 21) may engage opposite sides of stomach 100. Restrainingdevice 10 may be secured to stomach 100 using one or more sutures 34 tocouple restraining device 10 to stomach 100, and restraining device 100may be further positioned about stomach 100 by way of adjusting tape2026 positioned around restraining device 10. As shown in FIG. 21, tape2026 is positioned about restraining device 10 so to engage firstinterconnection arm 2016 and second interconnection arm 2018, wherebypulling tape 2026 in a direction shown by arrow C would cause firstengaging component 12 and second engaging component 16 to move closer toone another. Tape 2026 may have one or more detectable portions 2100positioned/imprinted thereon, so that a user of restraining device 10can “see” the adjustment of tape 2026 by way of fluoroscopy (ifdetectable portions 2100 are radioopaque), camera, or other meanswhereby portions of a device positioned within a body can be visualized,either directly or through some sort of technological means, to allow auser of such a device to adjust the same.

Furthermore, and as shown in FIG. 21, restraining device 10 may have acover flap 2012 positioned thereon to assist maintaining the placementof restraining device 10 about stomach 100. Cover flap 2012, as shown inFIG. 21, may be ultimately coupled to first engaging component 12 andsecond engaging component 16 (not shown in FIG. 21), so that afterrestraining device 10 is positioned about a stomach 100, cover flap 2012may be closed (initially secured to first engaging component 12 andclosed by way of securing cover flap 2012 to second engaging component16, or vice versa) about an upper portion of stomach 100.

As referenced above, restraining device 10 is positioned about stomach100 so not to exert pressure upon stomach 100, but when stomach 100becomes distended, stomach 100 exerts pressure/force upon first engagingcomponent 12 and second engaging component 16 of restraining device 10.

Steps of a method for delivering and positioning an embodiment of arestraining device 10, such as the embodiment shown in FIGS. 20 and 21,are shown in FIG. 22. As shown in FIG. 22, exemplary method 2200comprises the step of laparascopically inserting/advancing restrainingdevice 10 into a patient's body (an exemplary insertion step 2202). Inat least one embodiment, the restraining device 10 may be insertedthrough a 15 millimeter cannula under insufflation into the appropriatecavity of the patient's body. This may be achieved through use of anexemplary delivery device known in the art. At step 2202, first swivelarm 2000 and second swivel arm 2002 of restraining device 10 areswiveled/positioned in the substantially parallel position such that theoverall diameter of the restraining device 10 is sufficiently narrow forinsertion into the body.

At step 2204, restraining device 10 is advanced to a location adjacentto a targeted tissue, such as a stomach 100 (an exemplary advancementstep 2204). At step 2206 (an exemplary swivel step), first swivel arm2000 and second swivel arm 2002 of restraining device 10 are swiveledfrom a substantially parallel position to a substantially perpendicularposition, separating the first and second engaging components 12, 16from one another to a native interior space 70. Step 2206 may beperformed using any number of standard laparoscopic tools known in theart useful to pull and grasp portions of a tissue or a device. In thismanner, neither the proximal ends 13, 17 nor distal ends 14, 18 of thefirst and second engaging components 12, 16 of restraining device 10 areblocked by first swivel arm 2000 and second swivel arm 2002, and thefirst and second engaging components 12, 16 may be advanced over atargeted tissue, such as a stomach 100.

At step 2208, and under fluoroscopy, direct camera control or otherwise,restraining device 10 is positioned over the targeted tissue (anexemplary positioning step). In at least one embodiment, and at step2206, the first side 12A of the first engaging component 12 ispositioned adjacent to the desired surface of the targeted tissue andthe first side 16A of the second engaging component 16 is positionedadjacent to an opposite side of the targeted tissue. As the first andsecond engaging components 12, 16 of the restraining device 10 arepositioned adjacent to opposite sides of the targeted tissue, at thisstep 2208 the targeted tissue is positioned within the interior space 70formed between the first and second engaging components 12, 16. Further,due to the configuration and composition of restraining device 10,restraining device 10 can remain within the patient's body for as longas the restoration or support treatment delivered thereby is desired.

After restraining device 10 is positioned about a targeted tissue (byway of performing positioning step 2208), method 2200 may furthercomprise the optional steps of securing one or more sutures to connectrestraining device 10 to the targeted tissue (an exemplary suturing step2210), and may further comprise the step of securing cover flap 2012 tofurther secure restraining device about the targeted tissue (anexemplary cover flap step 2212). In addition, and as shown in FIG. 22,method 2200 may further comprise the step of adjusting tape 2026 tocontrol/adjust the interior space 70 between the first engagingcomponent 12 and the second engaging component 16 whereby at least aportion of the targeted tissue is positioned therebetween (an exemplarytape adjustment step 2214).

In the exemplary embodiment of a restraining device 10, as shown in FIG.23, restraining device 10 comprises one or more adjustment rods 2300coupled to the first swivel arm 2000 and the second swivel arm 2002. Inthe embodiment shown in FIG. 23, for example, adjustment rods 2300 arecoupled to first swivel arm 2000 and second swivel arm 2002 at or nearbends 2020, 2022, and are further coupled to a first interconnection arm2016 and a second interconnection arm 2018, respectively. As shown inFIG. 23, at in at least one embodiment, adjustment rods 2300 are coupledto first swivel arm 2000 and second swivel arm 2002 through swivel armapertures 2302 defined therethrough, and are further coupled to firstinterconnection arm 2016 and second interconnection arm 2018 throughinterconnection arm apertures 2304 defined therethrough.

Adjustment rods 2300, as shown in FIGS. 23 and 25, further comprise abar 2306 coupled to adjustment rods 2300 at or near a distal end 2308 ofadjustment rod 2300. Bar 2306, as shown in FIG. 24, is positioned distalto first interconnection arm 2016/second interconnection arm 2018, sothat adjustment of a dial 2310 coupled to adjustment rod 2300 causesmovement of first engaging component 12 and second engaging component 16toward or away from one another. As shown in FIG. 24, firstinterconnection arm 2016 and second interconnection arm 2018, in variousembodiments, may extend either completely or substantially along thelength of first swivel arm 2000 and second swivel arm 2002 distal tofirst interconnection arm 2016 and second interconnection arm 2018, sothat adjustment of dial 2310 facilitates movement of first swivel arm2000 and second swivel arm 2002, thus facilitating movement of firstengaging component 12 and second engaging component 16.

As shown in FIGS. 23-25, adjustment rod 2300 may further comprise a cap2312 coupled thereto at or near a proximal end 2314 of adjustment rod2300. Cap 2312, as shown in FIGS. 23-25, may prevent dial 2310 fromdisengaging adjustment rod 2300 so that when restraining device 10 ispositioned within a body, dial 2310 remains upon restraining device 10.Cap 2312, in at least one embodiment, may be bulbous/rounded at one endfor comfort when restraining device 10 is positioned within a body.

As shown in FIG. 24, dial 2310 may facilitate adjustment of device 10 byway of threads 2316 positioned along adjustment rod 2300. In such anembodiment, rotation of dial 2310 in a first direction would cause firstengaging component 12 and second engaging component 16 to move towardone another, and rotation of dial 2310 in a second/opposite directionwould cause first engaging component 12 and second engaging component 16to move away from one another. As such, restraining device 10 may bepositioned within a body about a stomach, for example, and be adjustedusing dial 2310 so that restraining device 10 is optimally positionedabout the stomach.

As shown in the exemplary embodiments in FIGS. 25 and 26, dial 2310 maydefine a dial aperture 2318, whereby indicia 2320 upon adjustment rod2300 may be viewed therethrough. As shown in FIG. 26, for example, asdial 2310 is rotated, one or more indicia 2320 may be visible throughdial aperture 2318, so that a user of such an embodiment of arestraining device 10 of the present disclosure may identify a level ofadjustment. Indicia 2320 may be one or more numbers, letters, linesand/or other indicia 2320 useful to identify a level of adjustment ofrestraining device 10.

As shown in FIG. 27, and in at least one embodiment of a restrainingdevice 10 of the present disclosure, restraining device 10 furthercomprises at least one flange 2700 coupled to first swivel arm 2000and/or second swivel arm 2002. Flange 2700 defines an aperturetherethrough so that adjustment rod 2300 may fit therethrough, providingphysical support for dial 2310 as dial 2310 engages said flange 2700.

An exemplary embodiment of a restraining device 10 of the presentdisclosure having adjustment rods 2300 is shown in FIG. 28. As shown inFIG. 28, first engaging component 12 and/or second engaging component 16may define one or more facets 2800 along at least part of the length ofsaid components 12, 16, whereby facets 2800 provide a generally arcuateprofile as shown therein. Facets 2800 may further improve the overallcomfort of restraining device 10 when it is positioned with a patient'sbody.

Steps of a method for delivering and positioning an embodiment of arestraining device 10, such as the embodiment shown in FIG. 23, areshown in FIG. 29. As shown in FIG. 29, exemplary method 2900 comprisesthe step of laparascopically inserting/advancing restraining device 10into a patient's body (an exemplary insertion step 2202) as previouslydiscussed herein. At step 2202, first swivel arm 2000 and second swivelarm 2002 of restraining device 10 are swiveled/positioned in thesubstantially parallel position such that the overall diameter of therestraining device 10 is sufficiently narrow for insertion into thebody.

At step 2204, restraining device 10 is advanced to a location adjacentto a targeted tissue, such as a stomach 100 (an exemplary advancementstep 2204). At step 2206 (an exemplary swivel step), first swivel arm2000 and second swivel arm 2002 of restraining device 10 are swiveledfrom a substantially parallel position to a substantially perpendicularposition, separating the first and second engaging components 12, 16from one another to a native interior space 70 as previously discussedherein.

At step 2208, and under fluoroscopy, direct camera control or otherwise,restraining device 10 is positioned over the targeted tissue (anexemplary positioning step) as previously referenced herein. Afterrestraining device 10 is positioned about a targeted tissue (by way ofperforming positioning step 2208), method 2900 may further comprise theoptional steps of securing one or more sutures to connect restrainingdevice 10 to the targeted tissue (an exemplary suturing step 2210), andregarding an embodiment of restraining device 10 of the presentdisclosure comprising a cover flap 2012, method 2900 may furthercomprise the step of securing cover flap 2012 to further securerestraining device about the targeted tissue (an exemplary cover flapstep 2212). In addition, and as shown in FIG. 29, method 2900 mayfurther comprise the optional step of rotating dial 2310 tocontrol/adjust the interior space 70 between the first engagingcomponent 12 and the second engaging component 16 whereby at least aportion of the targeted tissue is positioned therebetween (an exemplarydial adjustment step 2902).

An additional embodiment of a restraining device 10 of the presentdisclosure is shown in FIGS. 30 and 31. As shown in FIGS. 30 and 31,restraining devices 10 each comprise a first engaging component 12 and asecond engaging component 16, such as those provided in various otherembodiments herein. First engaging component 12 and second engagingcomponent 16, in such exemplary embodiments, are positioned relativelyparallel to one another. A first swivel arm 2000 and a second swivel arm2002 are pivotally connected to first engaging component 12 and secondengaging component 16, so that first swivel arm 2000 engages firstengaging component 12 at pivot point 2004 and engages second engagingcomponent 16 at pivot point 2006, and so that second swivel arm 2002engages first engaging component 12 at pivot point 2008 and engagessecond engaging component 16 at pivot point 2010. First swivel arm 2000and second swivel arm 2002 may swivel in the directions shown in arrowsA and B in FIGS. 30 and 31, noting that first swivel arm 2000 and secondswivel arm 2002 may move in opposite directions, so that one moves inthe direction of arrow A and the other moves in the direction of arrowB.

As shown in FIGS. 30 and 31, first swivel arm 2000 may comprise a firstarm member 3000 and a second arm member 3002, and second swivel arm 2002may comprise a first arm member 3020 and a second arm member 3022. Firstarm members 3000, 3020 and second arm members 3002, 3022 may each coupleto a hub 3004, 3024 as shown in FIGS. 30 and 31. In at least oneembodiment, and as shown in FIGS. 30 and 31, second arm members 3002,3022 may be fixedly coupled to hubs 3004, 3024, and first arm members3000, 3020 may slidingly engage said hubs 3004, 3024, whereby portionsof first arm members 3000, 3020 are positioned between hubs 3004, 3024and hub brackets 3006, 3026. First arm members 3000, 3020 may each haveat least one bend 3008, 3028 therein, as shown in FIGS. 30 and 31, tofacilitate said engagement of first arm members 3000, 3020 to hubs 3004,3024. First arm members 3000, 3020, in at least one embodiment, arecapable of movement relative to hubs 3004, 3024 in the directions shownin arrows C and D in FIGS. 30 and 31, whereby first arm members 3000,3020 move in a first direction until they contact hubs 3004, 3024, forexample, and move in a second direction until arm flanges 3010, 3030 offirst arm members 3000, 3020 contact hub brackets 3006, 3026, forexample. First arm members 3000, 3020 and second arm members 3002, 3022may be referred to as “fixed arms” if they are fixed to one of hubs3004, 3024, and may be referred to as “expandable arms” if they arecoupled to hubs 3004, 3024 by way of hub brackets 3006, 3026 tofacilitate movement relative thereto.

In at least one embodiment of an exemplary restraining device 10 of thepresent disclosure, and as shown in FIGS. 30 and 31, hub brackets 3006,3026 may be coupled to hubs 3004, 3024 by way of one or more fasteners3012, such as one or more screws, pins, rivets, and the like. Similarly,second arm members 3002, 3022 may be coupled to hubs 3004, 3024 by wayof one or more fasteners 3012. In at least one embodiment, first armmembers 3000, 3020 and/or second arm members 3002, 3022 are comprised ofstainless steel (such as 316LVM, or implant-grade stainless steel) hubs3004, 3024 are comprised of one or more polyaryletherketones (PEEKs),and hub brackets 3006, 3026 are also comprised of stainless steel. Firstengaging component 12 and second engaging component 16 may, in at leastone embodiment, comprise stainless steel which may then becoated/overmolded with a biocompatible polymer, such as polyurethane(PX205, for example) or tecothane (TT-1075D-M, for example).

In various embodiments of restraining devices 10 of the presentdisclosure, restraining devices 10 may comprise one or more pads 3014,3034 coupled to first arm members 3000, 3020 and/or second arm members3002, 3022. Said pads 3014, 3034 may comprise any number ofbiocompatible polymers and/or other materials that are suitable forcontacting an organ, such as a stomach, and which may provide some sortof cushioning effect. In at least one embodiment, pads 3014, 3034 may becomprised of a biocompatible polymer such as carbothane (such asPC-3595A), for example, and may be coupled to first arm members 3000,3020 and/or second arm members 3002, 3022 using one or more fasteners3012. In at least one embodiment, fasteners 3012, as referenced herein,may be comprised of stainless steel.

Regarding the exemplary embodiment of restraining device 10 shown inFIGS. 30 and 31, restraining device is shown in an open configuration inFIG. 30 and in a closed configuration in FIG. 31. As shown in FIG. 31,an exemplary restraining device 10 of the present disclosure maycomprise a strap 3100 coupled thereto at first engaging component 12 andsecond engaging component 16. In at least one embodiment, strap 3100 isfixedly coupled to one or both of first engaging component 12 and secondengaging component 16, and in another embodiment, strap is removablycoupled to one or both of first engaging component 12 and secondengaging component 16 by way of one or more sutures 32 (such as a 2-0silk suture, for example), as shown in FIG. 31. As shown in theembodiment of restraining device 10 in FIG. 31, a first end 3102 ofstrap 3100 is fixedly coupled to second engaging component 16, and asecond end 3104 of strap 3100 is removably coupled to first engagingcomponent 12 by way of suture 32. In practice, suture 32 may not bepositioned within suture aperture(s) 34 defined within one or morecomponents of restraining device 10 until after restraining device 10has been inserted into a mammalian body. In at least one embodiment, oneor more suture apertures 34 defined within one or more components ofrestraining device 10 may comprise/define one or more eyelets 3106,whereby said eyelets 3106 provide additional reinforcement/strength, andmay also provide a more smooth, rounded contour than suture apertures 34so not to cause unintended wear, and potential breakage, of one or moresutures 32 positioned therethrough. In at least one embodiment, strap3100 comprises carbothane (PC-3595A), and eyelets 3106 are comprised ofnickel. In at least another embodiment, strap 3100, or portions thereof,may be radiopaque.

FIGS. 32 and 33 show top views of exemplary restraining devices 10 ofthe present disclosure. As shown in FIG. 32, restraining device 10 isshown with first swivel arm 2000 and second swivel arm 2002 in apositioned whereby said arms 2000, 2002 are at least substantiallyperpendicular to first engaging component 12. As shown in FIG. 32, andin at least one embodiment of a restraining device 10 of the presentdisclosure, first swivel arm 2000 is relatively shorter than secondswivel arm 2002, whereby such a configuration allows for placement ofrestraining device 10 about a stomach, for example, as shown in FIGS.40, 41, and 42.

FIG. 33 shows an exemplary restraining device 10 whereby first swivelarm 2000 and second swivel arm 2002 share a common linear axis withfirst engaging component 12. In the configuration shown in FIG. 33, forexample, restraining device 10 may fit within a bodily laparoscopic portfor eventual swiveling of arms 2000, 2002 and placement of restrainingdevice 10 about an organ. FIG. 34 shows a front view of an exemplaryrestraining device 10 of the present disclosure in a similarconfiguration as shown in FIG. 33, and FIG. 35 shows a perspective viewof restraining device 10 in the same configuration.

FIGS. 36 and 37 show a side view and a perspective view, respectively,of an exemplary first swivel arm 2000 of the present disclosure. In atleast one embodiment, and as shown in FIG. 36, first swivel arm 2000 hasan interior length (as indicated by arrow A in the figure) of about 26.5mm, and has an expanded interior height (as indicated by arrow B in thefigure) of about 19.1 mm. In other embodiments, the interior length andinterior height may be greater or lesser than those shown in the figure.

As shown in FIGS. 36 and 37, an exemplary first swivel arm 2000 may haveone or more distal arm flanges 3600, which, in at least one embodiment,are bent relatively down/up and then out, as shown in the figures, sothat exemplary first swivel arm 2000 may engage first engaging component12 and second engaging component 16 while maintaining integrity of firstswivel arm 2000 and/or providing additional clearance for an organpositioned therebetween. In at least one embodiment, and as shown inFIG. 36, distal arm flanges 3600 result in an expanded flange height (asindicated by arrow C in the figure) of less than the expanded interiorheight. The relative distal ends of first swivel arm 2000, which maythemselves comprise distal arm flanges 3600, may comprise one or morearm apertures 3602 configured to receive, for example, one or morerivets 3604 (as shown in FIGS. 30 and 31) therethrough to couple firstswivel arm 2000 to a first engaging component 12 and a second engagingcomponent 16. In at least one embodiment, rivets 3604 are comprised ofstainless steel. In at least another embodiment, another type offastener 3012, as described herein, aside from a rivet 3604 may be used.

FIGS. 38 and 39 show a side view and a perspective view, respectively,of an exemplary second swivel arm 2002 of the present disclosure. In atleast one embodiment, and as shown in FIG. 38, second swivel arm 2002has an interior length (as indicated by arrow A in the figure) of about37 mm, and has an expanded interior height (as indicated by arrow B inthe figure) of about 18 mm. In other embodiments, the interior lengthand interior height may be greater or lesser than those shown in thefigure.

As shown in FIGS. 38 and 39, an exemplary second swivel arm 2002 mayalso have one or more distal arm flanges 3600, which, in at least oneembodiment, are bent relatively down/up and then out, as shown in thefigures, so that exemplary second swivel arm 2002 may engage firstengaging component 12 and second engaging component 16 while maintainingintegrity of second swivel arm 2002 and/or providing additionalclearance for an organ positioned therebetween. In at least oneembodiment, and as shown in FIG. 38, distal arm flanges 3600 result inan expanded flange height (as indicated by arrow C in the figure) ofless than the expanded interior height. The relative distal ends ofsecond swivel arm 2002, which may themselves comprise distal arm flanges3600, may comprise one or more arm apertures 3602 configured to receive,for example, one or more rivets 3604 (as shown in FIGS. 30 and 31)therethrough to couple second swivel arm 2002 to a first engagingcomponent 12 and a second engaging component 16.

FIG. 40 shows an exemplary embodiment of a restraining device 10, suchas shown in FIGS. 30 and 31, positioned about a stomach. As shown inFIG. 40, device 10 may be positioned about stomach 100 similar toplacement of restraining device 10 about stomach 100 as shown in FIGS.5B and 21, for example, so that the first engaging component 12 (notshown in FIG. 40) and the second engaging component 16 may engageopposite sides of stomach 100. Restraining device 10 may be secured tostomach 100 using one or more sutures 34 to couple restraining device 10to stomach 100, or one or more sutures 34 may be positioned withinsuture aperture(s) 34 within strap 3100 and one or both of firstengaging first engaging component 12 and second engaging component 16 tosecure restraining device 100 about a stomach 100. FIGS. 41 and 42 showadditional views of an exemplary restraining device 10 positioned abouta stomach 100.

An exemplary embodiment of a restraining device 10 of the presentdisclosure is shown in FIG. 43. As shown therein, restraining device 10comprises a first c-ring 4300 (which may also be referred to herein asan inferior c-ring (and also whereby the various c-rings 4300 or otherc-rings of the present disclosure may be exemplary swivel arms 2000,2002 or other couplers used to couple two engaging components 12, 16 ofthe present disclosure to one another, as generally described and shownherein)), whereby an inferior c-ring 4300 is relatively rigid andload-carrying in various embodiments, and whereby a superior c-ring 4400(shown in FIG. 44), in various embodiments, is relatively rigid on oneaxis and flexible on another axis. Engaging components 12, 16 may berelatively stiff and coated with some sort of coating 4302 (such as anelastomer coating or other coating) as tissue interface material. Theflexible coating 4302 can be flexible around the relative edges of theengaging components 12, 16, and excess flexible coating 4302, extendingsufficiently from the inner rigid plates 4312 and 4316, as shown in FIG.43, can gradually distribute any forces of the plates to the tissue(such as the stomach). The coating 4302 (which may also be referred toas a mattress or cushion) also helps prevent shearing and migration ofthe device 10 with respect to the device 10 rubbing against the tissueor organ. As shown in FIG. 43, for example, coating 4302 extends beyonda perimeter 4530 of each rigid plate 4312, 4316. As the stomach 100distends, for example, when an exemplary device 10 of the presentdisclosure is positioned therein, stomach tissue 100 can “roll” relativeto coating 4302, preventing migration of portions of device 10 intostomach 100 tissue.

Engaging components 12, 16 may also each comprise a tail 4322, 4326 atone end that is relatively flexible and generally comprising a coatingmaterial 4302 and not any sort of rigid material (such as used withrigid plates 4312, 4316) therein. The tails 4322, 4326 are shown in FIG.43. The strap 3100 (also referred to herein as a “fundus strap”) showntherein may comprise an embedded, load-carrying element (rigid innerportion 4500) inside of a silicone coating (an exemplary coating 4302).For example, nylon, PEEK mesh, and stainless steel foil can each beexemplary embedded elements 433) within a coating 4302 and still operateas a fundus strap 3100 consistent with the present disclosure. After thedevice 10 is positioned about a stomach 100 and a fundus strap 3100wrapped around an upper portion of the stomach 100 (such as from behindstomach 100) and locked into place, excess fundus strap 3100 may be cutoff. The fundus strap 3100 can be coupled to the anterior engagingcomponent 16 and lock onto the other engaging component 12. A hook orother mechanism (an exemplary tab 4600, as shown in FIG. 46) may be usedto lock a portion of the fundus strap 3100 to the plate (engagingcomponent 12 or 16) that does not have the fundus strap 3100 initiallycoupled thereto. Use of a fundus strap 3100, in various embodiments, isalso to effectively exclude the fundus 90 region from the flow of foodinto the stomach 100, further directing food to the channel (such asfirst stomach portion 110 referenced herein) created using the device 10and not to the fundus 90 area. Regarding overall load-carrying, at leastone purpose of using metal (or another rigid material) within theflexible/pliable coating 4302 (such as silicone) is to provideadditional strength and also to limit stretch of the portion of device10 (engaging components 12 and/or 16, fundus strap 3100, and/or c-arms,c-rings 4300 or 4400, or other connectors), so that the same do notdistend over time. As referenced herein, such a rigid material can beused with rigid inner plate 4312 and/or 4412 and/or other components asreferenced herein.

Each c-ring 4300, 4440 may have one, two, or three or more suturefeatures 4402 (such as and/or similar to suture members 36 having sutureapertures 32, for example, or other types of suture features) therein asshown in FIG. 44, such as one at a relative apex (middle) of one or bothc-rings 4300, 4400, and one between the apex and one end on an anteriorside of the device 10 when viewed as positioned upon a stomach 100.Suture features 4402 would allow one or more sutures 34 (also referredto herein as strings 34) to pass therethrough. The engaging components12, 16 may comprise a stiff inner portion (namely rigid inner plates4312, 4316, comprising material such as metal) and a flexible orcompressible outer coating 4302, such as silicone. Various holes 4350can be defined within the engaging components 12, 16 or within rigidinner plates 4312, 4316 as shown in FIG. 43, or a fundus strap 3100stiff inner portion, which can reduce the weight of the device 10 andallow the coating 4302 material to enter the holes 4350 and help withoverall binding of the coating 4302 to said components.

The c-rings 4300, 4400 can swivel about engaging components 12, 16, suchas about 90°, less, or more. Optional stops 4410 positioned on anengaging component 12 and/or 16 can be used to prevent c-rings 4300,4400 from swiveling further than desired.

A superior c-ring 4400 and/or an inferior c-ring 4300 can have one ormore suture holes (such as suture apertures 32 of suture members 36and/or suture features 4402) to allow sutures 34 to connect the device10 to the stomach 100. The superior c-ring 4400 and/or the inferiorc-ring 4300 can have an insert 4420, which can be flexible and/or metal,surrounded by silicone or another flexible/pliable material (such ascoating 4302) for tissue contact. Rivet holes 4430 can be defined at therelative ends of the superior c-ring 4400 to fasten the same to theengaging components 12, 16. The same or different coating 4302 can beused to coat/surround rigid inner plate 4312, 4316, and/or metalinsert(s) 4420.

The superior c-ring 4400 and/or the inferior c-ring 4300 can be flexiblein one plane but not two planes. For example, and as shown in FIG. 44,c-ring 4400 can be relatively stiff when pushed in a direction shown byarrow “A”, and can be relatively flexible when pushed in a directionshown by arrow “B”.

Distal portions of exemplary fundus straps 3100 are shown in FIGS. 45A,45B, and 45C. As shown in FIG. 45A, distal portion of fundus strap 3100has a rigid inner portion 4500 (such as metal) and optionally one ormore apertures 4502 or ridges 4504 defined therein, allowing a flexiblepolymer outer coating 4302 to better adhere and remain in contact withthe rigid inner portion 4500. An optional inner mesh 4510 (such as anylon mesh), as shown in FIG. 45B, can be embedded within the flexiblepolymer outer coating 4302 to provide additional support to the distalend of the fundus strap 3100. A portion of the rigid inner portion4500/mesh 4510 may have a mesh aperture 4512 defined therein, as shownin FIG. 45C, whereby a portion of the inner mesh 4510 can be positionedtherethrough to further hold the mesh 4510 in place. The various innerportion apertures 4502, ridges 4504, and mesh apertures 4512 can belaser welded, for example.

FIG. 46 shows ends of two engaging components 12, 16, with one having afundus strap 3100 coupled thereto. The engaging component 12 or 16 thatdoes not have the fundus strap 3100 coupled thereto (engaging component12, for example, as shown in FIG. 46), and in at least one exemplarydevice 10 embodiment of the present disclosure, has a loop 4602 and anoptional tab 4600 coupled thereto, whereby the loop 4602 defines anopening 4604 sized and shaped to receive a portion of the fundus strap3100 thereto, and wherein the fundus strap 3100 defines one or more tabapertures 4610 configured to receive the tab 4600. Use of the loop 4602and/or tab 4600 can secure the end of the fundus strap 3100 to the otherengaging component (such as engaging component 12, as shown in FIG. 46).In use, the end of the fundus strap 3100 can be positioned in the loopopening 4604 and either pushed or pulled therethrough until a desiredamount of connection is obtained, and further locked into place usingtab 4600 and tab aperture 4610. Tab 4600 can be angled or otherwiseconfigured to receive and secure the fundus strap 3100. The loop 4602can be made of metal or plastic. One of the purposes of such a design,and other designs of the present disclosure, is to aid in laparoscopicplacement and ease of handling and placement for the physician placingthe device 10 within the patient.

In various device 10 embodiments of the present disclosure, relativelyrectangular c-rings 4300, 4400 can fit through a 15 mm trocar and carrythe necessary load to maintain a desired engaging component gap. Forexample, FIGS. 47A and 47B show portions of exemplary restrainingdevices 10, whereby one or both c-rings 4300, 4310 (one c-ring (4300chosen for example) shown therein) has/have a first c-ring portion 4700and a second c-ring portion 4702 connected at a pivot point 4704 using acoupler 4706. Such an embodiment allows the first c-ring portion 4700 topivot relative to the second c-ring portion 4702 to reduce an overallcross-sectional size of the device 10, such as from changing from arelatively open swivel configuration shown in FIG. 47A to a relativelyclosed swivel position shown in FIG. 47B.

FIGS. 48A and B shows another embodiment of a portion of a device 10,whereby one or both c-rings 4300, 4400 (one shown, namely 4300 forexample, in FIGS. 48A and 48B) are configured to expand from arelatively closed configuration (FIG. 48A), such as for delivery througha trocar, to a relatively open configuration (FIG. 48B), for placementabout a stomach 100. In such an embodiment, the c-rings 4300, 4400 mayhave a first c-ring portion 4700 and a second c-ring portion, and oneportion (such as, for example, second c-ring portion 4702 shown in FIG.48B) may have a c-ring post 4800, and the other portion (such as, forexample, first c-ring portion 4700 shown in FIG. 48B) may have a c-ringpost aperture 4802 to receive the post 4800, allowing for such anexpansion to occur.

A slider coupler 4900, such as shown in FIGS. 49A and 49B, may also beused in connection with first and second c-ring portions. As shown inFIG. 49A, slider coupler 4900 is configured to receive, and slidinglyengage, and retain (at least temporarily) at least one of the first ringportion 4700 and/or the second c-ring portion 4702, allowing one or bothto move in the relative directions shown by the bold arrows in thefigure. One or both c-ring portions (such as the second c-ring portion4702 shown in FIG. 49B) can be separate from slider coupler 4900 andpositioned therein after delivery through the trocar. An engagementmechanism 4902 within slider coupler 4902 or coupled to a c-ring 4300can be used to maintain engagement of one or both c-rings 4300, 4400within slider coupler 4900.

FIG. 50A shows yet another embodiment of portions of an exemplary c-ring4300, 4400 (with first c-ring 4300 shown in the figure), whereby a firstc-ring portion 4700 is coupled to, or forms a portion of, a joiner 5000,with said joiner 5000 defining an inner threaded portion 5002 therein.The inner threaded portion 5002 would be configured to receive an outerthreaded portion 5004 of a second c-ring portion 4702, either bytwisting the joiner 5000 or one of the c-rings 4300, 4400, or by pushingthe c-rings 4300, 4400 toward one another. Another mechanism forcoupling two c-ring portions 4300, 4400 to one another may be, as shownin FIG. 50B, by defining a c-ring stub aperture 5050 (which may also bereferred to as a tab aperture) in one and having a c-ring stub 5052(which may also be referred to as a tab) extending from another, thec-ring stub aperture 5050 configured to receive the c-ring stub 5052.Once coupled together, a cover 5060 (such as a tubing portion, forexample) could be placed around the two c-ring portions 4300, 4400 tofurther hold the two portions 4300, 4400 together.

FIGS. 51A and 51B show c-ring portions 4700, 4702 having a two-parthinge 5100 therein, whereby pivot points 5102 defined therein allow onec-ring portion 4700 to pivot about a second c-ring portion 4702 at twolocations, allowing a portion of device 10 to move from a relativelyclosed configuration (shown in FIG. 51A) to a relatively openconfiguration (shown in FIG. 51B), in a direction shown by the boldarrow in FIG. 51B. Another embodiment, shown in FIGS. 52A and 52B, showc-ring portions 4300, 4400 (with c-ring portion 4300 shown in thefigures) connected to one another by way of a hinge unit 5200 configuredto swivel about two pivot points 5102 so that the device 10 can movefrom a relatively open configuration (shown in FIG. 52A) to a relativelyclosed configuration (shown in FIG. 52B).

FIGS. 53A and 53B show an exemplary elongated coupler 5300 of thepresent disclosure with two living hinges 5302 defined therein. Livinghinges 5302 allow the elongated coupler 5300 to flex in various ways,from a relatively straight configuration shown in FIG. 53A, to arelatively closed configuration in FIG. 53B, shown in FIG. 53B ascoupled to a second elongated coupler 5310. A first coupler slot 5304defined within the first elongated coupler 5300 can allow a portion ofthe second elongated coupler 5310 to pass therethrough, and a secondcoupler loop 5312 can be configured to receive a portion of the firstelongated coupler 5300. Elongated couplers 5300, 5310, can connect toengaging components 12, 16.

The different configurations shown in FIGS. 47A-53B are intended, invarious embodiments, to alter a cross-sectional size of the device 10 sothat the relative cross-sectional size is smaller during delivery of thedevice 10 into a patient and larger when the device 10 is positionedaround part of a stomach 100 or other bodily tissue.

FIG. 54 shows yet another device 10 embodiment of the presentdisclosure, whereby the one of the engaging components 12, 16 (shown asfirst engaging component 12) loops around and couples to the otherengaging component (shown as second engaging component 16). A componenttab 5400 defined at one end of the first engaging component 12 mayoptionally engage a tab receiver 5402 of the second engaging component16 to couple the two engaging components 12, 16 to one another.

FIGS. 55A and 55B show cross-sectional end views of exemplary engagingcomponents of the present disclosure. FIG. 55A shows a cross-sectionalend view of an exemplary engaging component 12, with first side 12A (theside that would contact a tissue, such as stomach 100) shown on thebottom and second side 12B (the side that would not contact a tissue)shown at the top. As shown therein, lobes 5500 of coating 4302 can beformed/present at the relative sides 5502 of engaging component 12, withlobes 5500 having a relatively larger cross-section 5504 than anotherportion of component 12, such as necks 5506 adjacent to lobes 5500,which have a relatively smaller cross-section 5508. Exemplary engagingcomponents 12 of the present disclosure can also comprise a protrusion5508, positioned at or near first side 12A, configured to provideadditional potential comfort to a user of device 10. FIG. 55B shows across-sectional end view of an exemplary engaging component 16, withfirst side 16A (the side that would contact a tissue, such as stomach100) shown on the bottom and second side 16B (the side that would notcontact a tissue) shown at the top. As shown therein, lobes 5500 ofcoating 4302 can be also formed/present at the relative sides 5502 ofengaging component 12 adjacent to necks 5506 as shown therein. Lobes5500, as shown in FIG. 55B, may extend toward first side 16A, noting thedifference between lobes 5500 shown in FIG. 55A, which extend away fromfirst side 12A. Exemplary engaging components 16 of the presentdisclosure can also comprise a protrusion 5508, positioned at or nearfirst side 16A, configured to provide additional potential comfort to auser of device 10.

Various c-rings, c-arms, couplers, and/or swivel arms described hereinand/or shown in the figures may relate to the same type of componentry,so features described for one may apply to the others in variousembodiments.

The various embodiments of restraining devices 10 described hereinprovide numerous benefits over the devices and systems of the prior art.An exemplary restraining device 10 may be inserted laparoscopicallyand/or endoscopically, is minimally invasive, completely reversible andavailable for chronic placement without the risk of complications.Furthermore, use of a restraining device 10 to treat and/or support atargeted tissue or organ produces a reduced amount of negative sideeffects than the procedures of the prior art for similar indications.While embodiments of restraining devices 10 are presented with respectto specific anatomy and treatment examples, the various restrainingdevices 10 and methods 300 may be expanded for use in treating anyorgan, limb or body structure that would benefit from reshaping,restoring, or added support provided through a reversible, easy to useand easy to implement technique for chronic placement.

Prior art focuses on creating a restrictive line through “clamps” tomimic the gastric sleeve. The disclosure of the present applicationprovides various loosely-fitting restraints (to prevent migration) andto affect motility of the stomach 100. The contractility or motilitycurve of the gastric tissue is substantially attenuated by an externalrestraint (as discussed below), thus affecting the movement of bolusthrough the stomach 100. Hence, the food volume will remain in the pouchlonger and lead to earlier distension which affects neuroactivity andmechanosensory elements of satiety. Hence, the principle of therestraining devices 10 of the present disclosure is based on flow(motility) unlike previous art that focuses on restrictive which risksmigration and erosion.

As described herein, placement of exemplary restraining devices 10through the lower curvature can be easily implemented as opposed toprocedures which approach the greater curvature where the liver anddiaphragm are in the proximity. Furthermore, various clips, clamps, orperforated plates known in the art which transverse the stomach 100 (asopposed to sleeve) can lead to substantial remodeling of the funduswhich would lead to weight regain after a period of time. As such, thevarious connectors of the disclosure of the present application operateto prevent overall stretch of stomach 100 and hence prevent remodeling.The stretch that leads to mechanosensory satiety in the restrainingdevices 10 of the present disclosure occurs locally between therestraining springs or bars while still restraining the overall pouch.No such global containment of the gastric tissue is known in the priorart. Finally, various clips, clamps, or perforated plates known in theart would exert significant local stresses on the tissue which can leadto erosion or migration as the substantially restricted stomach 100would attempt to distend. Conversely, the first engaging component 12and the second engaging component 16 of the restraining devices 10 ofthe present disclosure distribute the stress more uniformly over theplate and only restrain a relatively small pouch rather than a moresubstantial portion of the stomach 100 transversely.

While various embodiments of implantable restraining devices, systems,and methods for using the same have been described in considerabledetail herein, the embodiments are merely offered by way of non-limitingexamples of the disclosure described herein. It will therefore beunderstood that various changes and modifications may be made, andequivalents may be substituted for elements thereof, without departingfrom the scope of the disclosure. Indeed, this disclosure is notintended to be exhaustive or to limit the scope of the disclosure.

Further, in describing representative embodiments, the disclosure mayhave presented a method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described.Other sequences of steps may be possible. Therefore, the particularorder of the steps disclosed herein should not be construed aslimitations of the present disclosure. In addition, disclosure directedto a method and/or process should not be limited to the performance oftheir steps in the order written. Such sequences may be varied and stillremain within the scope of the present disclosure.

1. A device, comprising: a first engaging component comprising a firstrigid inner plate at least partially surrounded by a first flexiblecoating; a second engaging component; a first c-ring coupled to thefirst engaging component at a first pivot point and coupled to thesecond engaging component at a second pivot point; and a cover flapcoupled to either the first engaging component or the second engagingcomponent, the cover flap capable of either further coupling to thesecond engaging component when initially coupled to the first engagingcomponent or further coupling to the first engaging component wheninitially coupled to the second engaging component; wherein each of thefirst engaging component and the second engaging component define alongitudinal axis; wherein the device is further configured forplacement around at least part of a stomach; and wherein the firstc-ring is configured to swivel from a first position that issubstantially coplanar with the longitudinal axis of the first engagingcomponent and the longitudinal axis of the second engaging component toa second position that is substantially perpendicular with thelongitudinal axis of the first engaging component and the longitudinalaxis of the second engaging component.
 2. The device of claim 1, whereinthe second engaging component comprises a second rigid inner plate atleast partially surrounded by a coating selected from the groupconsisting of the first flexible coating and the second flexible coating3. The device of claim 1, further comprising: a second c-ring coupled tothe first engaging component at a third pivot point and coupled to thesecond engaging component at a fourth pivot point.
 4. The device ofclaim 3, wherein when the first c-ring and the second c-ring are notpositioned within the interior space between the first engagingcomponent and the second engaging component when in the second positionwhen the device is open.
 5. The device of claim 2, wherein the firstflexible coating extends beyond a perimeter of the first rigid plate andwherein the second flexible coating extends beyond a perimeter of thesecond rigid plate.
 6. The device of claim 5, wherein when the firstflexible coating extends beyond a perimeter of the first rigid plate andwhen the second flexible coating extends beyond a perimeter of thesecond rigid plate, the first flexible coating and the second flexiblecoating prevents shearing and migration of the device when the firstengaging component and the second engaging component contact thestomach.
 7. The device of claim 1, further comprising: a first swivelstop positioned along at least one of the first engaging component andthe second engaging component, the first swivel stop configured to limitswiveling of the first c-ring.
 8. The device of claim 3, wherein atleast one of the first c-ring and the second c-ring comprises at leastone suture feature.
 9. The device of claim 2, wherein the cover flapcomprises a first material surrounded at least substantially by acoating selected from the group consisting of the first flexiblecoating, the second flexible coating, and a third coating.
 10. Thedevice of claim 1, wherein at least one tab aperture is defined withinthe cover flap, wherein one of the first engaging component and thesecond engaging component further comprises a tab, and wherein the tabis configured for insertion into the tab aperture.
 11. The device ofclaim 10, wherein one of the first engaging component and the secondengaging component further comprises a loop coupled thereto, wherein atleast a portion of the cover flap is configured to fit within the loop.12. The device of claim 1, wherein one of the first engaging componentand the second engaging component comprises a component tab configuredto fit within a tab receiver of at the other of the first engagingcomponent and the second engaging component.
 13. The device of claim 3,wherein at least one of the first c-ring and the second c-ring comprisesa first c-ring portion and a second c-ring portion, and wherein thefirst c-ring portion and the second c-ring portion are configured tocouple to one another by way of a mechanism selected from the groupconsisting of a coupler, a post, a slider coupler, a joiner, a c-ringstub, a hinge, and an elongated coupler.
 14. The device of claim 3,wherein at least one of the first c-ring and the second c-ring comprisesa metal insert at least substantially surrounded by a coating selectedfrom the group consisting of the first flexible coating, the secondflexible coating, and a third coating.
 15. An implantable device,comprising: a first engaging component comprising a first rigid innerplate at least partially surrounded by a first flexible coating; asecond engaging component; a first c-ring coupled to the first engagingcomponent at a first pivot point and coupled to the second engagingcomponent at a second pivot point; and a cover flap coupled to eitherthe first engaging component or the second engaging component, the coverflap capable of either further coupling to the second engaging componentwhen initially coupled to the first engaging component or furthercoupling to the first engaging component when initially coupled to thesecond engaging component; wherein each of the first engaging componentand the second engaging component define a longitudinal axis; whereinthe device is further configured for placement around at least part of astomach; wherein the first c-ring is configured to swivel from a firstposition that is substantially coplanar with the longitudinal axis ofthe first engaging component and the longitudinal axis of the secondengaging component to a second position that is substantiallyperpendicular with the longitudinal axis of the first engaging componentand the longitudinal axis of the second engaging component; wherein thefirst flexible coating extends beyond a perimeter of the first rigidplate and wherein the second flexible coating extends beyond a perimeterof the second rigid plate; and wherein at least one tab aperture isdefined within the cover flap, wherein one of the first engagingcomponent and the second engaging component further comprises a tab, andwherein the tab is configured for insertion into the tab aperture.
 16. Amethod for using an implantable device, the method comprising the stepsof: inserting an implantable device into a mammalian body, theimplantable device comprising: a first engaging component comprising afirst rigid inner plate at least partially surrounded by a firstflexible coating, a second engaging component, a first c-ring coupled tothe first engaging component at a first pivot point and coupled to thesecond engaging component at a second pivot point, and a cover flapcoupled to either the first engaging component or the second engagingcomponent, the cover flap capable of either further coupling to thesecond engaging component when initially coupled to the first engagingcomponent or further coupling to the first engaging component wheninitially coupled to the second engaging component, wherein each of thefirst engaging component and the second engaging component define alongitudinal axis, wherein the device is further configured forplacement around at least part of a stomach, and wherein the firstc-ring is configured to swivel from a first position that issubstantially coplanar with the longitudinal axis of the first engagingcomponent and the longitudinal axis of the second engaging component toa second position that is substantially perpendicular with thelongitudinal axis of the first engaging component and the longitudinalaxis of the second engaging component; advancing the implantable deviceto a location within the mammalian body adjacent to a targeted tissue;swiveling the first c-ring so that the first c-ring is substantiallyperpendicular to the first engaging component and the second engagingcomponent; and positioning the first engaging component and the secondengaging component over the targeted tissue such that at least a portionof the targeted tissue is positioned therebetween.
 17. The method ofclaim 16, wherein when the targeted tissue expands in a directionbetween the first engaging component and the second engaging component,the targeted tissue exerts a force upon the first engaging component andthe second engaging component.
 18. The method of claim 16, wherein thestep of positioning is performed to position the first engagingcomponent and the second engaging component over at least part of thestomach.
 19. The method of claim 18, wherein the method is performed toreduce a potential amount of food intake by reducing or eliminating anamount of food that can enter a fundus of the stomach.
 20. The method ofclaim 18, further comprising the step of: securing the cover flap over afundus of the stomach so that the cover flap is secured to the firstengaging component and the second engaging component.